D
Patient 1
A CUSTOMER FROM (B)(6) REPORTED TO BIOM?RIEUX A MISIDENTIFICATION OF CORYNEBACTERIUM MACGINLEYI AS PROPIONIBACTERIUM ACNES AND EGGERTHELLA CATENAFORMIS, FOR A BACILLUS GRAM POSITIVE OCULAR SAMPLE, IN ASSOCIATION WITH THE VITEK? 2 ANC TEST KIT. THE CUSTOMER STATED THE IDENTIFICATION OF EGGERTHELLA CATENAFORMIS (96%) WAS GIVEN ON THE ANC CARD SEVERAL TIMES. THE CUSTOMER STATED THE BACTERIA WAS ANAEROBIC AND HAD GOOD GROWTH ON COS AND ANC AGAR. BIOM?RIEUX ADVISED THE CUSTOMER TO IDENTIFY THE ISOLATE WITH ANOTHER TECHNIQUE. THE ISOLATE WAS SENT TO AN EXTERNAL LABORATORY WHICH IDENTIFIED IT AS CORYNEBACTERIUM MACGINLEYI BY MALDI-TOF. THE CUSTOMER REPORTED THAT THE INCORRECT RESULTS WERE NOT REPORTED TO A PHYSICIAN AND DID NOT IMPACT PATIENT RESULTS OR TREATMENT. THERE WAS A DELAY IN REPORTING RESULTS. THE CUSTOMER RESULT COULD NOT BE CONFIRMED AS THE ISOLATE WAS NOT AVAILABLE FOR TESTING. THE TEST REPORTS WERE REQUESTED FROM THE CUSTOMER. THE ISOLATE WAS NOT AVAILABLE. A BIOM?RIEUX INTERNAL INVESTIGATION WAS CONDUCTED. CORYNEBACTERIUM MACGINLEYI IS NOT A CLAIMED SPECIES FOR THE ANC CARD. THE FOLLOWING STATEMENT IS LISTED IN THE LIMITATIONS SECTION OF THE PRODUCT LABELING: NEWLY DESCRIBED OR RARE SPECIES MAY NOT BE INCLUDED IN THE ANC DATABASE. SELECTED SPECIES WILL BE ADDED AS STRAINS BECOME AVAILABLE. TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION. A REVIEW OF QUALITY RECORDS CONFIRMED THAT ANC LOT 2440100103 MET THE CRITERIA FOR FINAL RELEASE AND PERFORMANCE TESTING. THE CUSTOMER RESULT WAS NOT DUPLICATED AS THE ISOLATE WAS NOT AVAILABLE FOR TESTING.