VITEK® 2 ANC TEST KIT
Received Apr 25, 2018
Report 1950204-2018-00162 · MDR key 7461442
Device
Product problems
- Incorrect Or Inadequate Test Results
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED DUE TO THE MISIDENTIFICATION OF A CORYNEBACTERIUM MACGINLEYI AS PROPIONIBACTERIUM ACNES ON THE VITEK® 2 V7.01 ANC CARD. THE SPECIES CORYNEBACTERIUM MACGINLEYI IS NOT INCLUDED IN ANC KNOWLEDGE BASE (KB). THE INTENDED RESULT TO CORYNEBACTERIUM MACGINLEYI WAS CONFIRMED ON VITEK® MS V3 (KB V3.0). THIS SPECIES IS NOT INCLUDED IN THE VITEK 2 ANC KB. THE ANC CARD PACKAGE INSERT CONTAINS THE FOLLOWING LIMITATION STATEMENT: "WARNING: TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION."
Description of Event or Problem
A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF CORYNEBACTERIUM MACGINLEYI FROM A PATIENT ISOLATE (EYE SORE), AS PROPONOBACTERIUM ACNES IN ASSOCIATION WITH THE VITEK® 2 ANC TEST KIT 20CARDS (LOT 2440440103). THE CUSTOMER STATED THAT WHILE TESTING A GRAM POSITIVE BACILLUS STRAIN FROM THE PATIENT ISOLATE ON COS AND CAN MEDIA, A GROWTH WAS OBSERVED THAT SUGGESTED A POTENTIAL CORYNEBACTERIUM SPECIES. THE CUSTOMER TESTED THE STRAIN ON THE ANC CARD, AND AN IDENTIFICATION OF PROPONOBACTERIUM ACNES (95%) WAS OBTAINED. THE CUSTOMER SENT THE STRAIN TO THE NATIONAL REFERENCE CENTER FOR TESTING AND THE RESULT WAS CORYNEBACTERIUM MACGINLEYI BY MASS SPECTROMETRY. NO INCORRECT RESULT WAS REPORTED TO THE CLINICIAN, BUT THERE WAS A 48 HOUR DELAY IN REPORTING RESULTS DUE TO COMPLEMENTARY TESTING. CORYNEBACTERIUM MACGINLEYI SPECIES IS NOT A CLAIMED SPECIES FOR VITEK 2 ANC CARDS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.