ID NOW COVID-19 2.0 TEST KIT 24T OUS
Report
- Report Number
- 1221359-2023-00396
- Event Type
- Malfunction
- Date Received
- February 24, 2023
- Date of Event
- February 8, 2023
- Report Date
- March 20, 2023
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QJR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED: B1, B2 : OUTCOMES ATTRIBUTED TO AE. AFTER FURTHER REVIEW OF THE EVENT, IT WAS IDENTIFIED THE SAMPLE WAS STORED IN VIRAL TRANSPORT MEDIUM (VTM) PRIOR TO TESTING. THE CUSTOMER WAS ADVISED THAT PER THE PRODUCT INSTRUCTIONS FOR USE (IFU) THE ID NOW COVID-19 ASSAY IS INTENDED FOR TESTING A SWAB DIRECTLY WITHOUT ELUTION IN VIRAL TRANSPORT MEDIA. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M222894 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 193-000 / LOT M222894, TEST BASE PART NUMBER 193-430 / LOT M222894. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M222894 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY FOR A PATIENT ON (B)(6) 2023. REPEAT TESTING WAS PERFORMED (X2), FIRST REPEAT TEST USING SAME PATIENT SAMPLE GENERATED A POSITIVE RESULT AND SECOND REPEAT TEST WITH NEW SAMPLE GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING (X2) WAS PERFORMED ONE AT MICROBIOLOGY LAB (PLATFORM - GENEXPERT) AND OTHER CARRIED OUT AFTER PATIENT BEING ADMITTED TO HOSPITAL (MICROBIOLOGY LAB - PLATFORM UNKNOWN) BOTH GENERATED NEGATIVE RESULTS RESPECTIVELY. THE CUSTOMER REPORTED THAT THE PATIENT WAS TESTED POSITIVE FOR COVID-19 PREVIOUSLY ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT WAS PLACED IN A COVID WARD AS A RESULT OF THE FALSE POSITIVE, HOWEVER THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY FOR A PATIENT ON (B)(6) 2023. REPEAT TESTING WAS PERFORMED (X2), FIRST REPEAT TEST USING SAME PATIENT SAMPLE GENERATED A POSITIVE RESULT AND SECOND REPEAT TEST WITH NEW SAMPLE GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING (X2) WAS PERFORMED ONE AT MICROBIOLOGY LAB (PLATFORM GENEXPERT) AND OTHER CARRIED OUT AFTER PATIENT BEING ADMITTED TO HOSPITAL (MICROBIOLOGY LAB PLATFORM UNKNOWN) BOTH GENERATED NEGATIVE RESULTS RESPECTIVELY. THE CUSTOMER REPORTED THAT THE PATIENT WAS TESTED POSITIVE FOR COVID-19 PREVIOUSLY ON (B)(6) 2022. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1731690 | ID NOW COVID-19 2.0 TEST KIT 24T OUS | REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | QJR | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | M222894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |