BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY
Report
- Report Number
- 1119779-2020-00405
- Event Type
- Malfunction
- Date Received
- September 25, 2020
- Date of Event
- September 15, 2020
- Report Date
- March 12, 2021
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- QKP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
EUA#: (B)(4). H6: INVESTIGATION SUMMARY: BD HAS RECEIVED SEVERAL CUSTOMER COMPLAINTS FOR FALSE POSITIVE RESULTS, WHEN USING BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. THE CURRENT INVESTIGATION CONCERNS MULTIPLE LOTS OF BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. BD TAKES A SYSTEMATIC APPROACH TO INVESTIGATING FALSE POSITIVE COMPLAINTS THAT ARE RECEIVED. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. RETAIN SAMPLES WERE TESTED FOR BATCH #: 0212777. THE DEFECT COULD NOT BE REPLICATED AND THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0212777. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS THAT WERE OBSERVED. IT IS RECOMMENDED THAT EACH CUSTOMER REVIEW THEIR WORKFLOW CAREFULLY TO ENSURE THAT THE PACKAGE INSERT IS BEING FOLLOWED AS WRITTEN. THE ROOT CAUSE IS UNDER INVESTIGATION AND WILL BE DOCUMENTED IN OUR QUALITY SYSTEM. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA#1878253) IS ALREADY INITIATED TO INVESTIGATE THE ROOT CAUSE AND SOME MITIGATION ACTIONS ARE ALREADY BEING ADDRESSED.
THE FOLLOWING FIELDS WERE CORRECTED WITH ADDITIONAL INFORMATION: D.3. MANUFACTURER NAME: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. D.4. DEVICE LOT NUMBER: 0212777; DEVICE EXPIRATION DATE: 2021-01-09. G.1. MANUFACTURING SITE: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. H.4. DEVICE MANUFACTURE DATE: 2020-07-30.
IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY 6 FALSE POSITIVE RESULTS WERE OBTAINED BY THE CUSTOMER. IT IS UNKNOWN WHAT TYPE OF CONFIRMATION TESTING WAS PERFORMED. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4).
IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY 6 FALSE POSITIVE RESULTS WERE OBTAINED BY THE CUSTOMER. IT IS UNKNOWN WHAT TYPE OF CONFIRMATION TESTING WAS PERFORMED. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4).
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY 6 FALSE POSITIVE RESULTS WERE OBTAINED BY THE CUSTOMER. IT IS UNKNOWN WHAT TYPE OF CONFIRMATION TESTING WAS PERFORMED. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1055199 | BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY | CORONAVIRUS ANTIGEN DETECTION SYSTEM | QKP | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | 0212777 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |