VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Oct 28, 2015
Report 1950204-2015-00079 · MDR key 5185359
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT A DISCREPANT ORGANISM IDENTIFICATION ON THE VITEK 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. A MORGANELLA MORGANII ORGANISM MISIDENTIFIED AS SERRATIA FONTICOLA. THE LABORATORY PROVIDED THE VITEK 2 GN ID RESULT OF SERRATIA FONTICOLA TO THE TREATING PHYSICIAN. IN ADDITION, THE CUSTOMER SENT THE PATIENT ISOLATE TO A REFERENCE LABORATORY FOR CONFIRMATORY TESTING. THE REFERENCE LABORATORY RETURNED AN ORGANISM IDENTIFICATION OF MORGANELLA MORGANII. THE LABORATORY UPDATED THE PHYSICIAN WITH THE NEW ID RESULT; ANTIBIOTIC TREATMENT DID NOT CHANGE, NO THERAPEUTIC FAILURE EVIDENT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.
Additional Manufacturer Narrative
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. INVESTIGATIONAL TESTING INCLUDED THE FOLLOWING METHODS: VITEK® 2 GN ID TEST KIT (CUSTOMER LOT). VITEK® 2 GN ID TEST KIT (RANDOM LOT). VITEK® MS. API® ID32E STRIP. TWO (2) DIFFERENT COLONIES WERE OBSERVED ON THE SAMPLE SUBCULTURE; BOTH COLONY TYPES WERE TESTED. COLONY A = SMALL WHITE COLONY, AND COLONY B = LARGE BROWN COLONY. TEST RESULTS: VITEK® 2 GN ID TEST KIT (CUSTOMER LOT) COLONY A - UNIDENTIFIED ORGANISM. COLONY B - MORGANELLA MORGANII. VITEK® 2 GN ID TEST KIT (RANDOM LOT) COLONY A - UNIDENTIFIED ORGANISM. COLONY B - MORGANELLA MORGANII. VITEK® MS: COLONY A - ENTEROCOCCUS FAECALIS. COLONY B - MORGANELLA MORGANII SSP MORGANII. API® ID32E STRIP: COLONY A - UNACCEPTABLE PROFILE. COLONY B - MORGANELLA MORGANII SSP MORGANII. THE CUSTOMER RESULT OF SERRATIA FONTICOLA WAS NOT CONFIRMED/REPRODUCED. THE VITEK® 2 GN ID CARD IS PERFORMING AS EXPECTED AND NO FURTHER ACTION IS REQUIRED.