VITEK® 2 GN ID TEST KIT
Received Nov 3, 2016 · Event occurred Aug 2, 2016
Report 1950204-2016-00163 · MDR key 6076661
Device
Generic name
Vitek® 2 Gn Id Test Kit
Manufacturer
Biomerieux, IncCatalog number
21341
Lot number
241373140
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A PHARMACEUTICAL CUSTOMER IN GERMANY CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF PARACOCCUS DENITRIFICANS AS BRUCELLA MELITENSIS IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. REPEAT TESTING OBTAINED THE SAME RESULTS. ALTERNATE METHOD TESTING MICROSEQID (MOLECULAR) OBTAINED THE PARACOCCUS DENITRIFICANS RESULT. THE CUSTOMER STATED THE DISCREPANT GN ID RESULTS WERE NOT REPORTED TO THE PHYSICIAN; THEREFORE, THESE RESULTS DID NOT AFFECT PATIENT TREATMENT. CULTURE SUBMITTAL WAS REQUESTED FROM THE CUSTOMER; THE ISOLATE IS NO LONGER AVAILABLE. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.
Additional Manufacturer Narrative
A PHARMACEUTICAL CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF PARACOCCUS DENITRIFICANS AS BRUCELLA MELITENSIS IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. PARACOCCUS DENITRIFICANS IS A GRAM NEGATIVE COCCI. THE VITEK® 2GN CARD IS INTENDED FOR USE WITH GRAM NEGATIVE BACILLI. THE PRECAUTIONS SECTION OF THE LABELING STATES: A GRAM STAIN SHOULD BE PERFORMED TO DETERMINE AN ORGANISM'S GRAM REACTION AND MORPHOLOGY PRIOR TO SELECTING THE IDENTIFICATION CARD TO INOCULATE. P. DENITRIFICANS IS NOT A CLAIMED SPECIES BY THE VITEK® 2 GN CARD. THE FOLLOWING LIMITATION IS LISTED IN THE PRODUCT LABELING: NEWLY DESCRIBED OR RARE SPECIES MAY NOT BE INCLUDED IN THE GN DATABASE. SELECTED SPECIES WILL BE ADDED AS STRAINS BECOME AVAILABLE. TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION. WHEN THE VITEK® 2 GN CARD MAKES A CALL OF BRUCELLA MELITENSIS, IT IS REPORTED AS A PRESUMPTIVE IDENTIFICATION AND SHOULD ALWAYS BE CONFIRMED WITH ANOTHER METHOD. IT SHOULD ALSO BE NOTED THAT THE CORRECT INCUBATION TEMPERATURE FOR STRAINS TESTED IN THE VITEK® 2 GN CARD IS 35-37C. ON 21NOV2016 INDUSTRIALIZATION- GN LOT 241373140 MET FINAL QC RELEASE CRITERIA. THERE WERE NO ISSUES OBSERVED ON INITIAL QC PERFORMANCE TESTING.