BD MAX¿ ENTERIC BACTERIAL PANEL
Received Sep 14, 2021 · Event occurred Aug 13, 2021
Report 3007420875-2021-00052 · MDR key 12471850
Device
Generic name
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Model number
442963Catalog number
442963
Lot number
UNKNOWN
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CULTURE WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MAX EBP RESULT WAS NEGATIVE BUT SALMONELLA WAS DETECTED BY CULTURE."
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CULTURE WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MAX EBP RESULT WAS NEGATIVE BUT SALMONELLA WAS DETECTED BY CULTURE."
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY : THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. (B)(4) UNKNOWN LOT # WAS PERFORMED BY THE VERIFICATION OF COMPLAINTS HISTORY. CUSTOMER REPORTED A FALSE NEGATIVE RESULT WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL (EBP) ASSAY. A NEGATIVE RESULT WAS OBTAINED ON A SAMPLE BUT SALMONELLA INFANTIS WAS IDENTIFIED IN CULTURE. THE CUSTOMER ASKED IF THE BD MAX¿ EBP ASSAY CAN DETECT THIS SPECIES AND WANTED INFORMATION TO UNDERSTAND THE SITUATION. NO KIT LOT NOR ANY DATA WAS PROVIDED FOR THE INVESTIGATION. DISCUSSION WITH THE ASSAY DEVELOPMENT GROUP CONFIRMED THAT SALMONELLA INFANTIS SHOULD BE DETECTED WITH THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY. MOREOVER, 65 SEQUENCES OF S. INFANTIS FROM GENEBANK WERE COMPARED TO THE SALMONELLA PRIMERS SEQUENCES INCLUDED IN BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY, AND ALL BUT ONE HAD 100% HOMOLOGY. UNFORTUNATELY, THE SAMPLE WAS NOT RECEIVED, AND THE INVESTIGATION WAS THUS LIMITED. MULTIPLE CAUSES COULD EXPLAIN THE CUSTOMER REPORTED DISCREPANT RESULTS BETWEEN THE CULTURE RESULT AND THE BDMAX RESULT BUT WITHOUT DATA, BD WAS UNABLE TO CONFIRM ANY. ALTHOUGH THE EXACT CAUSE FOR THE CUSTOMER ISSUE COULD NOT BE IDENTIFIED, BASED ON THE INVESTIGATION THE PRODUCT IS NOT SUSPECTED. THE ROOT CAUSE WAS NOT IDENTIFIED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). H3 OTHER TEXT : SEE H10.