BD MAX¿ ENTERIC BACTERIAL PANEL
Received Dec 2, 2022 · Event occurred Nov 18, 2022
Report 3007420875-2022-00073 · MDR key 15906287
Device
Generic name
Bd Max¿ Enteric Bacterial Panel
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Model number
442963Catalog number
442963
Lot number
2151513
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
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 BD MAX¿ ENTERIC BACTERIAL PANEL FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SALMONELLA POSITIVE, CULTURE NEGATIVE. CUSTOMER IS SEEING PCR POSITIVE SALMONELLA, WHEN THE CULTURE IS NEGATIVE. THIS HAS BEEN SEEN REPEATEDLY (FREQUENCY TO BE INVESTIGATED). THEY REPEATED THE PCR 2X ON THE BD MAX FOLLOWING THE NEGATIVE CULTURE AND THE PCR WAS THEN NEGATIVE. THEY BELIEVE TO EXCLUDE A CONTAMINATION, SINCE THEY SHOULD HAVE PCR+/CULTURE- CASES MUCH MORE REGULARLY, IF THIS WAS THE CASE. THESE RESULTS ARE ESPECIALLY CONCERNING SINCE THIS PROBLEM IS RECENT (SINCE THE MIDDLE OF THIS YEAR). THEY HAVE REACHED A POINT WHERE WE NO LONGER DARE TO REPORT A PCR SALMONELLA + RESULT WHEN THE CT IS > 30 (APPROXIMATELY) AND PREFER TO WAIT FOR THE CULTURE RESULT. IS THERE FEEDBACK FROM OTHER LABS? CT0894
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT (B)(4) WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT BD MAX¿ ENTERIC BACTERIAL PANEL FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SALMONELLA POSITIVE, CULTURE NEGATIVE. CUSTOMER IS SEEING PCR POSITIVE SALMONELLA, WHEN THE CULTURE IS NEGATIVE. THIS HAS BEEN SEEN REPEATEDLY (FREQUENCY TO BE INVESTIGATED). THEY REPEATED THE PCR 2X ON THE BD MAX FOLLOWING THE NEGATIVE CULTURE AND THE PCR WAS THEN NEGATIVE. THEY BELIEVE TO EXCLUDE A CONTAMINATION, SINCE THEY SHOULD HAVE PCR+/CULTURE- CASES MUCH MORE REGULARLY, IF THIS WAS THE CASE. THESE RESULTS ARE ESPECIALLY CONCERNING SINCE THIS PROBLEM IS RECENT (SINCE THE MIDDLE OF THIS YEAR). THEY HAVE REACHED A POINT WHERE WE NO LONGER DARE TO REPORT A PCR SALMONELLA + RESULT WHEN THE CT IS > 30 (APPROXIMATELY) AND PREFER TO WAIT FOR THE CULTURE RESULT. IS THERE FEEDBACK FROM OTHER LABS? CT0894