BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT
Report
- Report Number
- 3006948883-2025-00037
- Event Type
- Malfunction
- Date Received
- March 31, 2025
- Date of Event
- March 1, 2025
- Report Date
- May 8, 2025
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- GTY
- UDI-DI
- 00382902560401
- PMA / PMN Number
- K122718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 GRP A STREP 30 TEST VERITOR (MATERIAL#: 256040), BATCH NUMBER 4121812. THE CUSTOMER REPORTED THAT THEY INCUBATED THE SAMPLE ON THE CARTRIDGE FOR 9 MINUTES AND THE ANALYZER READ THE RESULT AS NEGATIVE, BUT THEN THEY LEFT THE CARTRIDGE TO FURTHER INCUBATE FOR AN ADDITIONAL 4 MINUTES AND RE-INSERTED INTO THE ANALYZER, GIVING A POSITIVE RESULT. 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 RESULTS WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. IT IS ADVISED FOR THE CUSTOMER TO FOLLOW THE INCUBATION TIME GUIDELINES IN THE IFU, AND TO NOT RE-INSERT USED CARTRIDGES IN THE ANALYZER. IF A RETEST IS DESIRED, IT IS ADVISED TO USE A NEW TEST CARTRIDGE. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.
IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, THE USER INCUBATED A TEST CARTRIDGE FOR APPROXIMATELY 9 MINUTES BEFORE INSERTING AND RECEIVING A GROUP A STREP NEGATIVE RESULT FROM THE ANALYZER. UPON VISUALLY INSPECTING THE TEST CARTRIDGE, A FAINT LINE WAS OBSERVED. THE TEST CARTRIDGE WAS THEN INCUBATED FOR ANOTHER 4 MINUTES AND WAS REINSERTED INTO THE ANALYZER PROVIDING A GROUP A STREP POSITIVE RESULT. NO CONFIRMATORY OR CULTURE TESTING WAS PERFORMED. THIS EVENT OCCURRED WITH 1 PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, THE USER INCUBATED A TEST CARTRIDGE FOR APPROXIMATELY 9 MINUTES BEFORE INSERTING AND RECEIVING A GROUP A STREP NEGATIVE RESULT FROM THE ANALYZER. UPON VISUALLY INSPECTING THE TEST CARTRIDGE, A FAINT LINE WAS OBSERVED. THE TEST CARTRIDGE WAS THEN INCUBATED FOR ANOTHER 4 MINUTES AND WAS REINSERTED INTO THE ANALYZER PROVIDING A GROUP A STREP POSITIVE RESULT. NO CONFIRMATORY OR CULTURE TESTING WAS PERFORMED. THIS EVENT OCCURRED WITH 1 PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 832689 | BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | GTY | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | 4121812 | 00382902560401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |