BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
Report
- Report Number
- 3006948883-2024-00053
- Event Type
- Malfunction
- Date Received
- April 24, 2024
- Date of Event
- March 22, 2024
- Report Date
- July 22, 2024
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- PSZ
- UDI-DI
- 00382902560456
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G.5. PMA / 510(K)#: K112277, K132259, K132692, K151291, K152870, K160161. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULT WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256045), BATCH NUMBER 3130394. THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT RESULT. ACCORDING TO THE CUSTOMER, THEY RECEIVED A POSITIVE RESULT, THEN THE TECHNICIAN OBSERVED MUCUS ON THE TEST STRIP, SO THEY DECIDED TO WAIT AN ADDITIONAL SEVERAL MINUTES AND READ THE SAME TEST DEVICE AGAIN, AND RECEIVED A NEGATIVE RESULT. THEY ALSO SPECIFIED THAT THEY OBSERVED THE MUCUS MOVE UP THE TEST STRIP DURING THOSE ADDITIONAL MINUTES. 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 OR SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULT WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.
IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, THE USER VISUALLY INSPECTED THE CARTRIDGE AND QUESTIONED THE RESULT. THE USER INSERTED THE CARTRIDGE INTO THE ANALYZER, WHICH READ IT AS POSITIVE, THEN REMOVED THE CARTRIDGE AND OBSERVED MUCUS MOVING UP IT. THE SAME CARTRIDGE WAS REINSERTED LESS THAN 5 MINUTES LATER, WHICH WAS THEN READ AS NEGATIVE BY THE ANALYZER. THE USER RECOLLECTED THE SAMPLE AND RERAN THE TEST, WHICH GAVE A NEGATIVE RESULT BY THE ANALYZER. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, THE USER VISUALLY INSPECTED THE CARTRIDGE AND QUESTIONED THE RESULT. THE USER INSERTED THE CARTRIDGE INTO THE ANALYZER, WHICH READ IT AS POSITIVE, THEN REMOVED THE CARTRIDGE AND OBSERVED MUCUS MOVING UP IT. THE SAME CARTRIDGE WAS REINSERTED LESS THAN 5 MINUTES LATER, WHICH WAS THEN READ AS NEGATIVE BY THE ANALYZER. THE USER RECOLLECTED THE SAMPLE AND RERAN THE TEST, WHICH GAVE A NEGATIVE RESULT BY THE ANALYZER. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1084789 | BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | PSZ | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | 3130394 | 00382902560456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |