VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Dec 10, 2015
Report 1950204-2015-00121 · MDR key 5285692
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. INVESTIGATIONAL TESTING INCLUDED: VITEK® 2 GN ID (CUSTOMER LOT AND RANDOM LOT): AN EXCELLENT IDENTIFICATION TO ESCHERICHIA COLI (99%) WAS OBTAINED ON BOTH GN ID CARD LOTS. THE INVESTIGATION DID NOT REPRODUCE THE MISIDENTIFICATION OBTAINED BY THE CUSTOMER. ID32E STRIP: VERY GOOD IDENTIFICATION TO ESCHERICHIA COLI (99.6%). THE VITEK® 2 GN ID CARDS ARE PERFORMING IN ACCORDANCE WITH SPECIFICATIONS.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN (B)(6) REPORTED THE VITEK 2 GRAM-NEGATIVE (GN) ID TEST KIT (REF (B)(4)) MISIDENTIFIED AN ESCHERICHIA COLI ORGANISM FROM A URINE SAMPLE AS SHIGELLA. UPON OBTAINING THE SHIGELLA IDENTIFICATION, THE CUSTOMER PERFORMED CONFIRMATORY TESTING VIA API 20E; THE IDENTIFICATION RESULT OBTAINED WAS ESCHERICHIA COLI. BIOMERIEUX HAS REQUESTED SUBMITTAL OF PATIENT ISOLATE FOR INTERNAL TESTING. 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. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.