Reviewing and Editing the Product Issues

Early in the investigation, the quality manager reviews, updates, and adds information to the product issue record. This record becomes the adverse event or complaint file for the investigation.

There are many fields in the product issue record. Some are filled in by the call center agent, some automatically, and others by the quality manager. Of particular importance are those fields that are used to populate the regulatory reports. For more information, see Regulatory Reporting

This task is a step in Process of Adverse Events and Complaints Investigation.

To review and edit a product issue

1. Navigate to the Product Issues screen, then the Product Issue List view.

2. In the Product Issues list, select a record.

3. In the Product Issues applet, modify the fields in the record as required.

   Some fields are described in the following table. Note that the letter and number combination in the last column indicates how this field maps to the 3500A form.

   Field	Comments	Mapping to 3500A Form
   Account	The name of the account associated with the product issue.	E1
   Address	Account address - street address.	E1
   Alert Age	The number of days since the product issue was identified as reportable. If an initial report has been filed, the alert age is the number of days that the product issue was marked reportable before the report was filed.
   Alert Date	The date when a representative of a company becomes aware that the event needs to be reported. For example, when: A call center agent captures the adverse event or complaint. An assessment indicates that the event is reportable.
   Area	The general categorization area for the product issue. This field is constrained by Type.
   City	Account address - city.	E1
   Contacts (Contact Last Name in list)	The last name of the customer contact associated with the product issue. These contacts can also be entered using the Contacts view of the Product Issues screen, then the Contacts view.	E1
   CSN	Customer service number. A unique number to identify the account.	E1
   Evaluation	This field appears in the list applet. It also appears in the form in the Investigation view.
   First Name	The first name of the investigator carrying out a particular clinical trial at a site.
   First Name (Contact First Name in list)	The first name of the customer contact associated with the product issue.	E1
   Investigator	The last name of the investigator carrying out a particular clinical trial at a site. If the product issue is associated with a clinical trial, this field is auto-populated with the last name of the investigator at the protocol site, specified in the Protocol number field.
   Mfg Report #	This field appears in the list applet. It also appears in the form in the Importer view.
   Occupation	Occupation of the contact. This is copied from the value of the Type field in the Contacts screen.	E3
   Open Age	The number of days since the product issue was opened, or, if the product issue is closed, this is the number of days that the product issue was open.
   Phone #	Contact’s work phone number.	E1
   PI #	Unique number to identify the product issue. It is auto-generated when the product issue is created.
   Postal Code	Account address - postal code.	E1
   Protocol #	Protocol number identifies the clinical trial at a site. If regulatory report is an IND safety report, enter the protocol number.	G6
   Provider	Indicates if the contact is a health professional.	E2
   Received (Received Date in list)	The date when a company representative became aware of the event.
   Reported FDA	Indicates if initial reporter sent a report to the FDA.	E4
   SR #	The service request from which the product issue was created.
   State	Account address - state.	E1
   Status	The current status of the product issue. The status of the product issue can be changed by the owner of the product issue, using the Review Complete, Close, and Reopen buttons. Changes to this field are tracked in the Approvals view.
   Sub Area	This further refines the area categorization. (The Area field constrains this drop-down list.)
   Sub Status	The Status field constrains this drop-down list.

4. In the Event Detail applet, modify the fields as required.

   Some fields are described in the following table. Note that the letter and number combination in the last column indicates how this field maps to the 3500A form.

   Field	Comments	Mapping to 3500A Form
   Event Type	Describes the type of event.	B1
   Event Date	The approximate date of the adverse event.	B3
   Description (Event Description in the list)	Detailed description of the event	B5
   # Occurrences	Number of times the event occurred before it was reported
   External Products	List of other medical products (for example, drugs, medical devices) used by patient at the time of the event and dates of use	C10 or D11
   Tests/Data	All appropriate relevant test and laboratory findings and dates	B6
   Life Threatening	Life Threatening	B2
   Disability	Disability	B2
   Hospitalization	Hospitalization	B2
   Congenital Anomaly	Congenital Anomaly	B2
   Relevant History	Relevant history, including preexisting medical conditions	B7
   Death	Death	B2
   Required Intervention	Required Intervention	B2
   Date of Death	Date of Death	B2
   Other	Describe the reported outcome if it was not covered in the previous selections	B2

5. In the Products applet, create new records and complete the necessary fields as required.

   Some fields are described in the following table. Note that the letter and number combination in the last column indicates how this field maps to the 3500A form.

   Field	Comments	Mapping to 3500A Form
   Product	The name of the product associated with the event	C1
   Lot #	Lot number of the product	C6, D4
   Asset #	Asset number for the product	D4
   Serial #	Serial number for the asset	D4
   Mfg Name	Full name of the manufacturer of the product	D3
   Mfg Date	The date the product was manufactured	H4
   Expiration Date	Expiration date of the lot or product	C7, D4
   Labeled Single Use	Indicates if the device is labeled for single use	H5
   Device Operator	Type of person operating or using the suspect medical product on the patient at the time of the event	D5
   Device Available	Indicates if the device is available for evaluation by the manufacturer	D10
   Return Date	Date that the device was shipped to the manufacturer	D10
   Device Type	Generic or common name of the suspect medical device	D2
   Reprocessed	Indicate if this is a single-use device that was reprocessed and reused on a patient	D8
   Reprocessor	Name and address of the reprocessor of the reused single-use device	D9
   NDC#	National drug code #	C9
   Part #	Part number	D4
   Implant Date	The implant date or best estimate for medical devices that are implanted in the patient	D6
   Explant Date	The date or best estimate for medical devices removed from a patient	D7
   Street Address	Manufacturer’s street address	D3
   City	Manufacturer’s address: City	D3
   Postal Code	Manufacturer’s address: Postal Code	D3
   State	Manufacturer’s address: State	D3
   Model #	Model number	D4
   Catalog #	Catalog number	D4
   Dose Per Unit	Dosage for each unit of drug	C2
   Frequency	Frequency of drug administration	C2
   Route Used	Route used to administer the drug	C2
   Indication	The indication for which the product was prescribed or used in this particular patient	C4
   Therapy From Date	The date drug administration was started (or best estimate)	C3
   Therapy To Date	The date drug administration was stopped (or best estimate)	C3
   Event Abated	Event abated after use stopped or dose reduced	C5
   Reintroduce Reoccur	Event reappeared after reintroduction	C8

6. Review any service requests associated with the product issue as follows:

   1. Drill down on the product issue record.

   2. Click the Service Request tab.

   3. Drill down on the SR #.