VITEK 2 NH TEST KIT
Received Oct 21, 2015
Report 1950204-2015-00074 · MDR key 5166014
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN FRANCE REPORTED THE VITEK 2 NEISSERIA HAEMOPHILUS (NH) ID TEST KIT ((B)(4)) MISIDENTIFIED A (B)(6). SIMULTANEOUS TESTING VIA PCR METHOD WAS PERFORMED; THE RESULT WAS POSITIVE FOR (B)(6). THE VITEK 2 RESULTS WERE NOT REPORTED TO THE CLINICIAN. THE PCR RESULT OF (B)(6) WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE ORGANISM MISIDENTIFICATION LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. THE CUSTOMER NO LONGER HAS THE ISOLATE STRAIN; SUBMITTAL FOR INVESTIGATION IS NOT POSSIBLE. THERE IS NO FIELD SAFETY CORRECTIVE ACTION ASSOCIATED WITH THIS EVENT. INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.
Additional Manufacturer Narrative
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. LAB REPORTS WERE REVIEWED. THERE WAS EVIDENCE OF SEVERAL ATYPICAL WELL REACTIONS SUGGESTING THE ORGANISM'S VIABILITY WAS COMPROMISED WHEN SETTING UP THE VITEK® 2 NH ID CARD, OR THE INOCULUM DENSITY WAS INSUFFICIENT. THE VIABILITY OF (B)(6) DECREASES UPON PROLONGED PERIODS OUTSIDE OF A CO2 ENVIRONMENT. AS THE CUSTOMER DID NOT SUBMIT THE ORGANISM OR RAW TEST DATA, FURTHER INVESTIGATION IS NOT POSSIBLE. EVALUATION OF BATCH RECORDS FOR VITEK® 2 NH ID LOT 245336910 INDICATES THE LOT PASSED ON INITIAL QC PERFORMANCE TESTING. THERE WERE NO ISSUES OBSERVED.