KIT GRP A STREP 30 TEST VERITOR
Report
- Report Number
- 3006948883-2023-00049
- Event Type
- Malfunction
- Date Received
- June 22, 2023
- Date of Event
- June 6, 2023
- Report Date
- August 14, 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
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES ¿DISCREPANT RESULTS¿ WHEN USING KIT GRP A STREP 30 TEST VERITOR (MATERIAL # 256040), BATCH NUMBER 3032098. IT WAS REPORTED BY THE CUSTOMER THAT DESPITE SEEING TWO RED LINES, THEY RECEIVED NEGATIVE RESULT WHEN INSERTING THE CARTRIDGE IN THE ANALYZER. BD REPRESENTATIVE INFORMED THE CUSTOMER THAT THE RED LINES ARE NOT WHAT THE READER USES AND THAT THEY AREN'T A REFLECTION OF THE RESULTS. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING 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. BASED ON THE AVAILABLE INFORMATION IT WAS UNDERSTOOD THAT THE CUSTOMER HAD PERFORMED THE TEST AND RECEIVED A VALID RESULT (POSITIVE) THEN THEY RE-INSERTED THE SAME CARTRIDGE IN THE INSTRUMENT, AND IT GAVE A NEGATIVE RESULT. BD REPRESENTATIVE ADVISED THE CUSTOMER THAT THIS TEST NEVER BEEN DESIGNED TO BE READ VISUALLY; THE TEST RESULTS NEED TO BE ANALYZED THROUGH THE BD ANALYZER, ALSO THE SAME TEST CARTRIDGE SHOULD NOT BE REINSERTED. THIS COMPLAINT WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULT WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. NO CORRECTIVE ACTIONS WERE TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H.10.
H3. 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 THE KIT GRP A STREP 30 TEST VERITOR, 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 THAT DURING USE WITH THE KIT GRP A STREP 30 TEST VERITOR, 3 DISCREPANT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS STATED THEY WOULD LOOK AT THE TEST DEVICE AND IT WOULD HAVE 2 RED LINES BUT WHEN INSERTED IN THE INSTRUMENT IT GIVES A NEGATIVE RESULTS. THEY HAVE ALSO RECEIVED A POSITIVE RESULT BEFORE AND WHEN RE-INSERTED IN THE INSTRUMENT, IT GIVES A NEGATIVE RESULT. ADVISED THE CUSTOMER THAT RESULTS ARE NOT MEANT TO BE VISUALLY INTERPRETED. 2ND LINE COULD BE FROM NONSPECIFIC BINDING. THE RESULTS SHOULD ONLY BE FROM THE INSTRUMENT ITSELF AND NOT FROM VISUAL INTERPRETATION. TEST DEVICES ARE ALSO MUST ONLY BE INSERTED INTO THE INSTRUMENT ONCE AND NO MORE THAN THAT.
IT WAS REPORTED THAT DURING USE WITH THE KIT GRP A STREP 30 TEST VERITOR, 3 DISCREPANT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS STATED THEY WOULD LOOK AT THE TEST DEVICE AND IT WOULD HAVE 2 RED LINES BUT WHEN INSERTED IN THE INSTRUMENT IT GIVES A NEGATIVE RESULTS. THEY HAVE ALSO RECEIVED A POSITIVE RESULT BEFORE AND WHEN RE-INSERTED IN THE INSTRUMENT, IT GIVES A NEGATIVE RESULT. ADVISED THE CUSTOMER THAT RESULTS ARE NOT MEANT TO BE VISUALLY INTERPRETED. 2ND LINE COULD BE FROM NONSPECIFIC BINDING. THE RESULTS SHOULD ONLY BE FROM THE INSTRUMENT ITSELF AND NOT FROM VISUAL INTERPRETATION. TEST DEVICES ARE ALSO MUST ONLY BE INSERTED INTO THE INSTRUMENT ONCE AND NO MORE THAN THAT.
IT WAS REPORTED WHILE USING THE KIT GRP A STREP 30 TEST VERITOR, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 969680 | KIT GRP A STREP 30 TEST VERITOR | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | GTY | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | 256040 | 3032098 | 00382902560401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |