ID NOW COVID-19 2.0 TEST KIT 24T OUS
Report
- Report Number
- 1221359-2023-00655
- Event Type
- Malfunction
- Date Received
- April 25, 2023
- Date of Event
- April 11, 2023
- Report Date
- June 29, 2023
- Manufacturer
- ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
- Product Code
- QJR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M231855 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 M231855, TEST BASE PART NUMBER 192-430 / LOT M231855. 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 M231855 SHOWED THAT THE COMPLAINT RATE IS 0.259%. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, ABBOTT DIAGNOSTICS SCARBOROUGH WAS ABLE TO DETERMINE FROM THE LOGFILES THAT THE FALSE POSITIVE WAS DUE TO A VALID POSITIVE RESULT. A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. 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 INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. 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 INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2023. CONFIRMATION PCR TESTING (PLATFORM - UNKNOWN) WAS PERFORMED AND GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED TESTING WAS BEING CONDUCTED PRIOR TO SURGERY. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2023. CONFIRMATION PCR TESTING (PLATFORM - UNKNOWN) WAS PERFORMED AND GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED TESTING WAS BEING CONDUCTED PRIOR TO SURGERY. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2023. CONFIRMATION PCR TESTING PLATFORM UNKNOWN. PERFORMED AND GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED TESTING WAS BEING CONDUCTED PRIOR TO SURGERY. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540656 | ID NOW COVID-19 2.0 TEST KIT 24T OUS | REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | QJR | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | M231855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |