VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Sep 28, 2015
Report 1950204-2015-00051 · MDR key 5108555
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 THE UNITED STATES CONTACTED BIOMERIEUX TO REPORT A DISCREPANT ORGANISM IDENTIFICATION ON THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT ((B)(4)). A PROTEUS MIRABILIS ORGANISM MISIDENTIFIED AS MORGANELLA MORGANII. SAMPLE WAS INITIALLY TESTED ON MOLECULAR-VERIGENE, REPEATED ON VITEK 2 AND API. INCORRECT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. 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 A 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. THE CUSTOMER DID NOT COMPLY WITH BIOMÉRIEUX REQUEST FOR PATIENT ISOLATE AND LAB REPORT SUBMITTAL. QUESTIONING OF THE CUSTOMER DETERMINED THEIR SALINE DISPENSER HAD NOT BEEN AUTOCLAVED FOR A MONTH. THE CUSTOMER REPORTED THAT STRAINS ARE GROWN IN 4-6% CO2. THIS ENVIRONMENT IS NOT INCLUDED IN THE GRAM-NEGATIVE (GN) CULTURE REQUIREMENTS TABLE. STRAINS THAT ARE TESTED OUTSIDE OF THE RECOMMENDED CULTURE REQUIREMENTS MAY GIVE ATYPICAL RESULTS. THE VITEK® 2 GN KNOWLEDGE BASE CONTAINS SIX (6) WELL REACTIONS TO SEPARATE PROTEUS MIRABILIS FROM MORGANELLA MORGANII. WITHOUT THE LAB REPORT, IT IS NOT POSSIBLE TO FURTHER EVALUATE ANY ATYPICAL REACTIONS THE CUSTOMER MAY HAVE OBTAINED. AS NO PATIENT ISOLATE WAS SUBMITTED BY THE CUSTOMER, IT IS NOT POSSIBLE TO FURTHER INVESTIGATE THE CAUSE OF THE MISIDENTIFICATION. THE CUSTOMER REPORTED THEY ARE NOW SCREENING ALL SWARMING COLONIES WITH AN INDOLE TEST AND HAVE SINCE AUTOCLAVED THEIR DISPENSER. THEY ARE NO LONGER SEEING THE ISSUE. EVALUATION OF THE MANUFACTURING QC BATCH RECORD FOR GN ID LOT 241347040 INDICATES THE LOT PASSED ON INITIAL QC PERFORMANCE TESTING. THERE WERE NO ISSUES OBSERVED. COMPLAINT HISTORY REVIEW WAS COMPLETED FOR PROTEUS MIRABILIS AND RESULTED IN ONLY THIS COMPLAINT DURING THAT TIMEFRAME. THE INVESTIGATION CONCLUDED THE VITEK® 2 GN ID CARD IS PERFORMING AS INTENDED. CUSTOMER SPECIMEN PREPARATION (INCORRECT INCUBATION ENVIRONMENT AND SALINE CONTAMINATION) IS THE MOST LIKELY CAUSE OF THE REPORTED MISIDENTIFICATION.