BD MAX¿ ENTERIC BACTERIAL PANEL
Received Aug 17, 2021 · Event occurred Aug 5, 2021
Report 3007420875-2021-00043 · MDR key 12334515
Device
Generic name
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Model number
442963Catalog number
442963
Lot number
1068104
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
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INCREASED POSITIVITY RATE WITH STX, ONE FALSE POSITIVE RESULT."
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY (REF. (B)(4)) LOT 1068104 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS AND THE VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. ACCORDING TO COMPLAINT TEXT, CUSTOMER STARTED TO USE THE BD MAX¿ ENTERIC BACTERIAL PANEL KIT LOT 1068104 AND NOTICED AN INCREASE OF STX POSITIVITY RATE. FOUR POSITIVE RESULTS WERE CULTIVATED AND TWO OF THEM GAVE POSITIVE IN CULTURE, ONE DID NOT GROW AND THE LAST ONE WAS NOT YET AVAILABLE. HOWEVER, NO PCR DATA WAS PROVIDED FOR ANALYSIS, DESPITE REQUESTS TO OBTAIN SOME. BASED ON THE INVESTIGATION, THE CAUSE OF THE CUSTOMER ISSUE REMAINS UNKNOWN. 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 LOT 1068104. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA).
Additional Manufacturer Narrative
INITIAL REPORTER LAST NAME: (B)(6). 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 POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "INCREASED POSITIVITY RATE WITH STX, ONE FALSE POSITIVE RESULT."