ID NOW COVID-19 ASSAY
Report
- Report Number
- 1221359-2022-00873
- Event Type
- Malfunction
- Date Received
- February 11, 2022
- Date of Event
- December 28, 2021
- Report Date
- May 6, 2022
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QJR
- UDI-DI
- 10811877011269
- PMA / PMN Number
- EUA2000074
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-00849 - 1221359-2022-00905.
THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-00849 - 1221359-2022-00905.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. PLEASE SEE UPDATES: G3, G6, H2 AND H6. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1053298 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 190-000 / LOT 1053298 AND TEST BASE PART NUMBER 190-430 / LOT 105329. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS 0.002%. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION. A REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED CLOSED. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.
THE CUSTOMER REPORTED FIFTY-SEVEN FALSE NEGATIVES WITH THE IDNOW COVID-19 ASSAY PERFORMED ON VARIOUS DATES INVOLVING VARIOUS LOTS. THIS REPORT IS TWENTY-FIVE (25) OF FIFTY-SEVEN (57) AND ADDRESSES LOT 1053298 (TOTAL QUANTITY 1). THE CUSTOMER REPORTED ONE FALSE NEGATIVE WITH THE IDNOW COVID-19 ASSAY PERFORMED ON A NASAL SAMPLE (COLLECTION DATE: (B)(6) 2021). CONFIRMATION TESTING (PLATFORM: DIASORIN) ON A NASOPHARYNGEAL SAMPLE COLLECTED ON (B)(6) 2021 IN VIRAL TRANSPORT MEDIUM GENERATED A POSITIVE RESULT. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.
THE CUSTOMER REPORTED FIFTY-SEVEN FALSE NEGATIVES WITH THE IDNOW COVID-19 ASSAY PERFORMED ON VARIOUS DATES INVOLVING VARIOUS LOTS. THIS REPORT IS TWENTY-FIVE (25) OF FIFTY-SEVEN (57) AND ADDRESSES LOT 1053298 (TOTAL QUANTITY 1). THE CUSTOMER REPORTED ONE FALSE NEGATIVE WITH THE IDNOW COVID-19 ASSAY PERFORMED ON A NASAL SAMPLE (COLLECTION DATE: (B)(6) 2021). CONFIRMATION TESTING (PLATFORM: DIASORIN) ON A NASOPHARYNGEAL SAMPLE COLLECTED ON (B)(6) 2021 IN VIRAL TRANSPORT MEDIUM GENERATED A POSITIVE RESULT. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74795 | ID NOW COVID-19 ASSAY | MOLECULAR IVD FOR ID NOW COVID-19 | QJR | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 1053298 | 10811877011269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |