BD MAX¿ ENTERIC BACTERIAL PANEL
Received Nov 14, 2023 · Event occurred Oct 26, 2023
Report 3007420875-2023-00105 · MDR key 18133141
Device
Generic name
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
442963
Lot number
3137726
Product problems
- False Positive Result
- False Positive Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ ENTERIC BACTERIAL PANEL KIT (REF. (B)(4)) LOT 3137726 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX ENTERIC BACTERIAL PANEL (EBP) LOT 3137726 INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT SUSPECTED FALSE POSITIVE RESULTS WITH BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOT 3137726. ACCORDING TO THE CUSTOMER, THEY OBTAINED SAMPLES HAVING UNEXPECTED DOUBLE POSITIVE RESULTS. THEY OBTAINED CAMPY/STX POSITIVE TARGETS WHEN ONLY A CAMPY POSITIVE RESULT WAS EXPECTED, AND SALMONELLA/STX POSITIVE TARGETS WHEN ONLY A SALMONELLA POSITIVE RESULT WAS EXPECTED. HOWEVER, NO DATA OR ADDITIONAL INFORMATION WAS PROVIDED, DESPITE SEVERAL REQUESTS TO RECEIVE INFORMATION FROM THE CUSTOMER. WITHOUT DATA, THE INVESTIGATION WAS THUS LIMITED. BD IS UNABLE TO IDENTIFY THE CAUSE OF THE CUSTOMER ISSUE, ALTHOUGH NO REAGENT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOT 3137726. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.
Description of Event or Problem
IT WAS REPORTED WHILE TESTING WITH BD MAX¿ ENTERIC BACTERIAL PANEL A FALSE POSITIVE WAS OBTAINED. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS ALSO REPORTED UNEXPECTED DOUBLE POSITIVES WITH STX THEY HAVE DONE ENVIRONMENTAL CONTROL AND THERE IS NO CONTAMINATION DETECTED. SALMONELLA/STX CAMPYLO/STX FALSE RESULTS HAVE NOT BEEN REPORTED TO PHYSICIAN. THERE HAS BEEN NO HARM TO PATIENTS.
Additional Manufacturer Narrative
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHILE TESTING WITH BD MAX¿ ENTERIC BACTERIAL PANEL A FALSE POSITIVE WAS OBTAINED. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS ALSO REPORTED UNEXPECTED DOUBLE POSITIVES WITH STX THEY HAVE DONE ENVIRONMENTAL CONTROL AND THERE IS NO CONTAMINATION DETECTED. SALMONELLA/STX CAMPYLO/STX FALSE RESULTS HAVE NOT BEEN REPORTED TO PHYSICIAN. THERE HAS BEEN NO HARM TO PATIENTS.