BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
Report
- Report Number
- 1119779-2020-01208
- Event Type
- Malfunction
- Date Received
- January 13, 2021
- Date of Event
- November 3, 2020
- Report Date
- October 26, 2021
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- QKP
- UDI-DI
- 00382902560661
- 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 FIELD WAS UPDATED WITH CORRECTED INFORMATION: D.1 MEDICAL DEVICE TYPE: QKP.
THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: D.1 MEDICAL DEVICE TYPE: JJQ.
THE FOLLOWING FIELD WAS UPDATED WITH CORRECTED INFORMATION: D.1. MEDICAL DEVICE BRAND NAME: BD RAPID DETECTION OF SARS-COV-2 VERITOR¿.
H6: INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVES WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER UNKNOWN. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVES COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION COULD NOT BE PERFORMED AS NO BATCH NUMBER WAS PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. HOWEVER, THERE IS A TREND AGAINST FALSE POSITIVE RESULTS. BD HAS INITIATED CAPA (CORRECTIVE AND PREVENTIVE ACTION) 1878253 TO FURTHER INVESTIGATE. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.
IT WAS REPORTED THAT WHILE USING BD VERITOR PLUS ANALYZER WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ IT SHOWS A POSITIVE RESULT ON EVERY COVID TEST PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4).
IT WAS REPORTED THAT WHILE USING BD VERITOR PLUS ANALYZER WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ IT SHOWS A POSITIVE RESULT ON EVERY COVID TEST PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4).
IT WAS REPORTED THAT WHILE USING BD VERITOR PLUS ANALYZER WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ IT SHOWS A POSITIVE RESULT ON EVERY COVID TEST PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).
IT WAS REPORTED THAT WHILE USING BD VERITOR PLUS ANALYZER WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ IT SHOWS A POSITIVE RESULT ON EVERY COVID TEST PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4)
(B)(4). MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT WHILE USING BD VERITOR PLUS ANALYZER WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ IT SHOWS A POSITIVE RESULT ON EVERY COVID TEST PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54654 | BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ | CORONAVIRUS ANTIGEN DETECTION SYSTEM | QKP | BECTON, DICKINSON & CO. (SPARKS) | 256066 | NA | 00382902560661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |