KIT BD MAX EXT ENTERIC BACTERIAL PANEL
Report
- Report Number
- 3007420875-2024-00084
- Event Type
- Malfunction
- Date Received
- September 20, 2024
- Date of Event
- July 9, 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
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT (REF. 443812) LOTS: 4030731, 4051425 AND 4080024 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT SEVEN DISCREPANT RESULTS THAT TESTED POSITIVE WHEN USING BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL KIT LOTS: 4030731, 4051425 OR 4080024 BUT WERE TESTED NEGATIVE BY AN EXTERNAL LABORATORY. THE REVIEW OF MANUFACTURING RECORDS OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL INDICATED THAT LOTS: 4030731, 4051425 AND 4080024 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUN FILES (B)(4) FROM INSTRUMENT CT3207 FOR INVESTIGATION. CUSTOMER DESIGNATED AS TO INVESTIGATE THE POSITIVE RESULTS THAT WERE OBTAINED FOR ETEC IN RUN (B)(4); POSITION B9 (TESTED WITH KIT LOT: 4030731), (B)(4); A6 (TESTED WITH KIT LOT: 4051425), (B)(4); B3, (B)(4); A3 AND (B)(4); B4 (TESTED WITH KIT LOT: 4080024), AND FOR VIBRIO IN RUN (B)(4); POSITIONS A3 AND A5 (TESTED WITH KIT LOT: 4080024). THEY ALL CAME BACK NEGATIVE WHEN TESTED BY AN EXTERNAL LABORATORY. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ALL THE POSITIVE SAMPLES INDICATED BY THE CLIENT IN THE COMPLAINT TEXT. SAMPLES IN RUN (B)(4); POSITION B9, (B)(4); A6, (B)(4); B3 AND (B)(4); A3 ALL SHOW LATE OR LATE AND LOW, BUT TRUE POSITIVE RESULTS FOR ETEC. SAMPLE IN RUN (B)(4); POSITION B4 SHOWS A STRONG POSITIVE RESULT FOR ETEC. SAMPLES IN RUN (B)(4); POSITIONS A3 AND A5 SHOWS LATE AND LOW, BUT TRUE POSITIVE RESULTS FOR VIBRIO. 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 SAMPLES THAT SHOW LATE RESULTS SUGGEST SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION DURING SAMPLE PREPARATION. THE POSITIVE SAMPLE IN RUN (B)(4) DISPLAYS A STRONG POSITIVE AMPLIFICATION INDICATING A TRUE POSITIVE RESULT. THE LATE POSITIVE RESULTS 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 LOTS: 4030731, 4051425 OR 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. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.
REPORT 7 OF 7: IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL, A FALSE POSITIVE PATIENT RESULT FOR ENTEROTOXIGENIC E. COLI (ETEC) WAS OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY (B)(6), AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
REPORT 7 OF 7: IT WAS REPORTED THAT DURING USE OF THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL, A FALSE POSITIVE PATIENT RESULT FOR ENTEROTOXIGENIC E. COLI (ETEC) WAS OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY (B)(6), AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1483177 | KIT BD MAX EXT 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 |