BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL
Report
- Report Number
- 3007420875-2024-00079
- Event Type
- Malfunction
- Date Received
- September 20, 2024
- Date of Event
- July 21, 2024
- Report Date
- November 1, 2024
- Manufacturer
- GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
- Product Code
- PCH
- UDI-DI
- 00382904438128
- PMA / PMN Number
- K214122
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4. MEDICAL DEVICE LOT #: 4080024 D4. MEDICAL DEVICE EXPIRATION DATE: 13-SEP-2025 H4. DEVICE MANUFACTURE DATE: 20-MAR-2024 D.4 UDI#: (B)(4). INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT (REF. 443812. LOT 4080024 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT A DISCREPANT RESULT THAT TESTED POSITIVE WHEN USING THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT LOT 4080024 BUT WAS TESTED NEGATIVE BY AN EXTERNAL LABORATORY. THE REVIEW OF MANUFACTURING RECORDS OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL INDICATED THAT LOT 4080024 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUN 225 FROM INSTRUMENT CT3207 FOR INVESTIGATION. CUSTOMER DESIGNATED AS TO INVESTIGATE SAMPLE IN RUN 225; POSITION B2 THAT TESTED POSITIVE FOR ETEC TARGET BUT CAME BACK NEGATIVE WHEN TESTED BY AN EXTERNAL LABORATORY. MANUAL PCR CURVE ADJUDICATION OF THE POSITIVE SAMPLE SHOWS LATE AND LOW, BUT TRUE POSITIVE RESULTS FOR ETEC. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA BUT BASED ON THE ANALYSIS. THE LATE POSITIVE RESULT COULD EXPLAIN THE DISCREPANCY WITH THE REFERENCE LABORATORY. IT MUST BE NOTED THAT LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. NO INFORMATION WAS PROVIDED ABOUT THE ANALYSIS METHOD USED BY THE EXTERNAL LABORATORY. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT LOT 4080024. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, AND VARIATION BETWEEN ASSAYS ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED. B. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.
D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL, A FALSE POSITIVE ENTEROTOXIGENIC E. COLI (ETEC) PATIENT RESULT WAS OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY THE ILLINOIS DEPT. OF PUBLIC HEALTH (IDPH), AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED THAT DURING USE OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL, A FALSE POSITIVE ENTEROTOXIGENIC E. COLI (ETEC) PATIENT RESULT WAS OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY THE ILLINOIS DEPT. OF PUBLIC HEALTH (IDPH), AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1392945 | BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL | GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM | PCH | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 4080024 | 00382904438128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |