BD MAX¿ ENTERIC BACTERIAL PANEL
Report
- Report Number
- 3007420875-2023-00088
- Event Type
- Malfunction
- Date Received
- September 21, 2023
- Date of Event
- July 18, 2023
- Report Date
- August 14, 2025
- Manufacturer
- GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
- Product Code
- PCI
- UDI-DI
- 00382904429638
- PMA / PMN Number
- K140111
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: H.3: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. 442963) FROM LOTS 3137729 AND 3081371 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT LOTS 3137729 AND 3081371 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT SUSPECTED STX FALSE POSITIVE RESULTS WHEN USING BD MAX¿ ENTERIC BACTERIAL PANEL KIT FROM LOTS 3081371 AND 3137729. CUSTOMER PROVIDED DATABASE FROM INSTRUMENT CT1164 FOR INVESTIGATION. SAMPLES A3, A5, A9, A12 AND B8 IN RUNS #3048 AND SAMPLES A1, A5 AND A9 IN RUN #3096 MENTIONED BY THE CUSTOMER IN THE COMPLAINT TEXT AS SUSPECTED STX FALSE POSITIVE. BOTH RUNS # 3048 AND #3096 WERE EXTRACTED AND MANUAL PCR CURVE ADJUDICATION OF THE SUSPECTED STX FALSE POSITIVE RESULTS WAS DONE. THE PCR CURVES ANALYSIS REVEALED THAT ALL THE STX POSITIVE RESULTS WERE LINKED TO ATYPICAL CURVES, AND UNLIKELY TRUE POSITIVES, EXCEPT FOR THE SAMPLE TESTED IN POSITION B8 (RUN 3048), WHICH APPEARS TO BE A TRUE STRONG STX POSITIVE SAMPLE. DATABASE ANALYSIS SHOWED THAT INSTRUMENT PUMP #1 PRESENTED A HIGHER UNRESOLVED RATE THAN THE OTHER PUMPS. THIS INFORMATION WAS TRANSFERRED TO BD SERVICE AND A COMPLAINT ON THIS INSTRUMENT IS ALREADY OPENED FOR FURTHER INVESTIGATION. DATA ANALYSIS DID NOT SUGGEST SPECIFIC LOTS LINKED TO POSITIVE RESULTS ISSUES. OVERALL, BASED ON THE INVESTIGATION AND DATA PROVIDED, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS ALTHOUGH AN INSTRUMENT RELATED ISSUE IS SUSPECTED OF BEING INVOLVED. THE ROOT CAUSE WAS NOT IDENTIFIED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY LOTS 3081371 AND 3137729. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.
AWARENESS DATE IS CHANGED FROM 2023-07-18 TO 2023-09-14 H3 OTHER TEXT : SEE H.10.
THE FOLLOWING FIELDS HAVE BEEN UPDATED TO REFLECT THE DEVICE EVALUATION PREVIOUSLY SUBMITTED: H6 IMDRF ANNEX B: B15 - ANALYSIS OF INFORMATION PROVIDED BY USER/THIRD PARTY, B17 - DEVICE NOT RETURNED, B11 - HISTORICAL DATA ANALYSIS, B14 - ANALYSIS OF PRODUCTION RECORDS. H6 IMDRF ANNEX C: C19 - NO DEVICE PROBLEM FOUND. H6 IMDRF ANNEX D: D14 - NO PROBLEM DETECTED. H6 IMDRF ANNEX G: G03001 - ANALYZER.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3137729. D4. MEDICAL DEVICE EXPIRATION DATE: 2024-11-30. H4. DEVICE MANUFACTURE DATE: 2023-05-17. D4. MEDICAL DEVICE LOT #: 3081371. D4. MEDICAL DEVICE EXPIRATION DATE: 2024-10-12. H4. DEVICE MANUFACTURE DATE: 2023-03-22. H.3. 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: THERE ARE TWO POTENTIAL LOT NUMBERS FOR THIS DEVICE: D4. MEDICAL DEVICE LOT #: 3137729. D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 17-MAY-2023. D4. MEDICAL DEVICE LOT #: 3081371. D4. MEDICAL DEVICE EXPIRATION DATE: 12-OCT-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 22-MAR-2022. B5. IT WAS REPORTED WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR 11910483.
IT WAS REPORTED THAT WHILE USING THE BD MAX¿ ENTERIC BACTERIAL PANEL THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX EBP - 442963_3137729 - FALSE POSITIVES.
IT WAS REPORTED THAT WHILE USING THE BD MAX¿ ENTERIC BACTERIAL PANEL THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) - FALSE POSITIVES.
IT WAS REPORTED THAT WHILE USING THE BD MAX¿ ENTERIC BACTERIAL PANEL THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX EBP - 442963_3137729 - FALSE POSITIVES.
IT WAS REPORTED THAT WHILE USING THE BD MAX¿ ENTERIC BACTERIAL PANEL THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX EBP - 442963_3137729 - FALSE POSITIVES.
IT WAS REPORTED WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 615029 | BD MAX¿ ENTERIC BACTERIAL PANEL | GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM | PCI | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | SEE H.10 | 00382904429638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |