BCID2 PANEL
Received Sep 14, 2023
Report MW5145662 · MDR key 17754898
Device
Generic name
Fungal Organisms, Nucleic Acid-based Assay
Manufacturer
Biomerieux Sa/biofire Diagnostics, LlcLot number
0592323
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
FALSE POSITIVE C. TROPICALIS (CANDIDA TROPICALIS) RESULTS ON BACTEC PLUS AEROBICS AND PED PLUS BLOOD CULTURE BOTTLES AND LYTIC/10 AEROBIC /F CULTURE AND AEROBIC PLUS MEDIA WHEN TESTED BY MOLECULAR TESTING WITH BIOFIRE BCID2 PANEL. CAUSE IS CONSIDERED TO BE DNA FROM ORGANISM CONTAMINATING CULTURE MEDIA. THIS WAS REPORTED TO MANUFACTURER (BD) WHO DENIES PROBLEM. MULTIPLE FACILITIES IN THE V.A. (VETERAN'S ADMINISTRATION) NEW ENGLAND REGION HAVE NOTICED THE SAME PROBLEM. I FEAR THAT THIS PROBLEM MAY LEAD TO FALSE POSITIVES BEING REPORTED WHICH COULD LEAD TO UNNECESSARY TREATMENTS AND COSTS. CULTURE MEDIA SHOULD BE FREE OF FOREIGN DNA, ESPECIALLY NOWADAYS GIVEN HOW OFTEN MOLECULAR TESTS ARE USED DOWNSTREAM OF CULTURES. REFERENCE REPORTS: MW5145659, MW5145660, MW5145661.