ID NOW COVID 19 ASSAY
Report
- Report Number
- 1221359-2022-01159
- Event Type
- Malfunction
- Date Received
- February 24, 2022
- Date of Event
- January 12, 2022
- Report Date
- July 6, 2022
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QJR
- UDI-DI
- 10811877011320
- PMA / PMN Number
- EUA2000074
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR NUMBERS: 1221359-2022-01146 THROUGH 1221359-2022-01327.
ADDITIONAL INFORMATION: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR NUMBERS: 1221359-2022-01146 THROUGH 1221359-2022-01327.
TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M169940 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 191-000 / LOT M169940, TEST BASE PART NUMBER 190-430 / LOT M169940. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4) . IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 191-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 190-000. REFERENCE MFR NUMBERS: 1221359-2022-01146 THROUGH 1221359-2022-01307.
THE CUSTOMER REPORTED 182 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT FOURTEEN (14) AND IS FOURTEEN (14) OF ONE HUNDRED EIGHTY-TWO (182). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED NASOPHARYNGEAL SWAB (MIRACLEAN TECHNOLOGY CO LTD). PCR CONFIRMATION TESTING WAS PERFORMED USING ALINITY M PLATFORM GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CUSTOMER REPORTED 182 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT FOURTEEN (14) AND IS FOURTEEN (14) OF ONE HUNDRED EIGHTY-TWO (182). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED NASOPHARYNGEAL SWAB (MIRACLEAN TECHNOLOGY CO LTD). PCR CONFIRMATION TESTING WAS PERFORMED USING ALINITY M PLATFORM GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CUSTOMER REPORTED 162 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT FOURTEEN (14) AND IS FOURTEEN (14) OF ONE HUNDRED SIXTY -TWO (162).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2358584 | ID NOW COVID 19 ASSAY | MOLECULAR IVD FOR ID NOW COVID-19 | QJR | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | M169940 | 10811877011320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |