BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B
Report
- Report Number
- 3006948883-2024-00095
- Event Type
- Malfunction
- Date Received
- December 13, 2024
- Date of Event
- November 25, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- QMN
- UDI-DI
- 00382902560883
- PMA / PMN Number
- SEE H.11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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: 11-FEB-2025. THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B ASS (MATERIAL#: 256088), BATCH NUMBER: 4190377 AND UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED FALSE POSITIVE RESULTS FROM THE ANALYZER. ONE SPECIMEN WAS RECOLLECTED FOR PCR TESTING, WHICH RETURNED AS A NEGATIVE RESULT. HOWEVER, THEY ARE UNABLE TO CONFIRM THE LOT NUMBER ASSOCIATED WITH THIS PCR TEST. 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: 4190377. BHR REVIEW AND RETAIN SAMPLE TESTING CANNOT BE PERFORMED ON BATCH NUMBER UNKNOWN. THE RESULTS WERE ACCEPTABLE FOR 4190377 BHR REVIEW. HOWEVER, THE RETAINED PRODUCT FOR 4190377 RESULTED IN ONE DEVICE WITH A FLU B FALSE POSITIVE USING RV REAGENT D DUE TO A SCRATCH BELOW THE FLU B LINE POSITION. ADDITIONALLY, ANOTHER DEVICE RESULTED IN A TEST INVALID (FLU A POSITIVE AND FLU B POSITIVE) USING THE FLU B NEGATIVE CONTROL SWAB. THERE WERE NO PHOTOGRAPHS RECEIVED. THERE WERE RETURN SAMPLES RECEIVED. THESE RETURN SAMPLES WERE TESTED WITH CONTROL SWABS AND RESULTED IN PASSING RESULTS. THE REPORTED ISSUE WAS CONFIRMED THROUGH RETAIN TESTING. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.
B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE INFORMATION FOR THE ADDITIONAL LOT # IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: UNKNOWN. THE INFORMATION FOR THE 510K IS AS FOLLOWS: G4. 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 UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO KNOWN LOT NUMBER 4190377. B5. IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B, THERE WAS A FALSE POSITIVE RESULT FOR FLU B. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR 11910483.
IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B, THE CUSTOMER QUESTIONED AN UNSPECIFIED NUMBER OF PATIENT FLU B POSITIVE RESULTS DUE TO THE HIGH NUMBER OBTAINED FROM THE VERITOR ANALYZER. RESULTS WERE REPORTED TO THE PHYSICIAN AND THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. NO CONFIRMATORY TESTING WAS PERFORMED EXCEPT FOR ONE PATIENT SAMPLE. THE SAMPLE WAS RECOLLECTED AND PCR TESTING PROVIDED A NEGATIVE FLU B RESULT. THE KIT BATCH NUMBER ASSOCIATED WITH THE RECOLLECTED/CONFIRMED SAMPLE WAS UNKNOWN. EUA#: (B)(4).
IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B, THE CUSTOMER QUESTIONED AN UNSPECIFIED NUMBER OF PATIENT FLU B POSITIVE RESULTS DUE TO THE HIGH NUMBER OBTAINED FROM THE VERITOR ANALYZER. RESULTS WERE REPORTED TO THE PHYSICIAN AND THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. NO CONFIRMATORY TESTING WAS PERFORMED EXCEPT FOR ONE PATIENT SAMPLE. THE SAMPLE WAS RECOLLECTED AND PCR TESTING PROVIDED A NEGATIVE FLU B RESULT. THE KIT BATCH NUMBER ASSOCIATED WITH THE RECOLLECTED/CONFIRMED SAMPLE WAS UNKNOWN. EUA# (B)(4).
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B, THERE WAS A FALSE POSITIVE RESULT FOR FLU B. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2412710 | BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B | ANTIGEN DETECTION REAGENT KIT | QMN | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | 4190377 | 00382902560883 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |