BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2
Report
- Report Number
- 3006948883-2024-00071
- Event Type
- Malfunction
- Date Received
- August 30, 2024
- Date of Event
- July 4, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- QKP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 09-AUG-2024. INVESTIGATION SUMMARY THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE NEGATIVE WHEN USING BD VERITOR¿ SARS-COV-2 KIT (MATERIAL#: 256082), BATCH NUMBER 4081455. THE CUSTOMER REPORTED THAT THEY SAW THE CONTROL LINE AND THE TEST LINE ON THE CARTRIDGE, BUT RECEIVED A NEGATIVE RESULT FROM ANALYZER WHEN THEY TESTED A PATIENT WITH SYMPTOMS. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. NO PHOTOS WERE RECEIVED. RETURN SAMPLES WERE RECEIVED ON THE BATCH NUMBER PROVIDED. THEY WERE TESTED AND THE RESULTS WERE ACCEPTABLE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR FALSE NEGATIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.
PMA/510(K)#: EUA# (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2, THE CUSTOMER QUESTIONED THREE (3) COVID NEGATIVE RESULTS OBTAINED FROM THE ANALYZER. AFTER VISUALLY READING THE TEST CARTRIDGE CONTROL AND TEST LINES, THE CUSTOMER THEN COMPARED THIS WITH THE PATIENT SYMPTOMS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. EUA# (B)(4).
IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2, THE CUSTOMER QUESTIONED THREE (3) COVID NEGATIVE RESULTS OBTAINED FROM THE ANALYZER. AFTER VISUALLY READING THE TEST CARTRIDGE CONTROL AND TEST LINES, THE CUSTOMER THEN COMPARED THIS WITH THE PATIENT SYMPTOMS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. EUA# (B)(4).
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1802819 | BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 | CORONAVIRUS ANTIGEN DETECTION SYSTEM | QKP | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | 4081455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |