BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY
Report
- Report Number
- 3006948883-2020-00531
- Event Type
- Malfunction
- Date Received
- October 12, 2020
- Date of Event
- September 17, 2020
- Report Date
- August 24, 2021
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- QKP
- UDI-DI
- 00382902560821
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, 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 #: 242768. THE DEFECT COULD NOT BE REPLICATED AND THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 242768. 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. H3 OTHER TEXT : SEE H10.
BD WAS MADE AWARE OF A SURVEY THAT WAS DISTRIBUTED TO SKILLED NURSING FACILITIES USING THE VERITOR ANALYZER AND ASSAY FOR RAPID DETECTION OF SARS-COV-2. SURVEY RESULTS REVEALED THAT SOME FACILITIES HAVE POTENTIALLY RECEIVED FALSE POSITIVE RESULTS WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY. SURVEY RESPONDENTS STATED THEY ARE SENDING POSITIVE SAMPLES FOR CONFIRMATION TESTING BY PCR. SOME OF THE SITES PARTICIPATING IN THE SURVEY STATED THEY ARE TESTING ASYMPTOMATIC AND SYMPTOMATIC PATIENTS AND STAFF. NOTE: THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS. ATTEMPTS HAVE BEEN MADE TO CONTACT CUSTOMERS FOR ADDITIONAL INFORMATION, BD HAS NOT RECEIVED A RESPONSE AT THIS TIME. EUA#: (B)(4).
THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6), USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). EUA#: (B)(4).
BD WAS MADE AWARE OF A SURVEY THAT WAS DISTRIBUTED TO SKILLED NURSING FACILITIES USING THE VERITOR ANALYZER AND ASSAY FOR RAPID DETECTION OF SARS-COV-2. SURVEY RESULTS REVEALED THAT SOME FACILITIES HAVE POTENTIALLY RECEIVED FALSE POSITIVE RESULTS WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY. SURVEY RESPONDENTS STATED THEY ARE SENDING POSITIVE SAMPLES FOR CONFIRMATION TESTING BY PCR. SOME OF THE SITES PARTICIPATING IN THE SURVEY STATED THEY ARE TESTING ASYMPTOMATIC AND SYMPTOMATIC PATIENTS AND STAFF. NOTE: THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS. ATTEMPTS HAVE BEEN MADE TO CONTACT CUSTOMERS FOR ADDITIONAL INFORMATION, BD HAS NOT RECEIVED A RESPONSE AT THIS TIME. EUA#: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1131428 | BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY | CORONAVIRUS ANTIGEN DETECTION SYSTEM | QKP | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | 242768 | 00382902560821 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |