VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Sep 11, 2015
Report 1950204-2015-00030 · MDR key 5071978
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 (B)(6) REPORTED THE VITEK 2 GRAM-NEGATIVE (GN) ID TEST KIT (REF 21341) MISIDENTIFIED A SHIGELLA ORGANISM AS ESCHERICHIA COLI (E. COLI). THE SAMPLE IS FECES FROM A CHILD. CONFIRMATORY TESTING VIA CPS AGAR AND API ALSO RETURNED A RESULT OF E. COLI. AGGLUTINATION WAS POSITIVE FOR SHIGELLA; SAMPLE WAS SENT TO THE NATIONAL AUTHORITY WHERE IT WAS IDENTIFIED AS SHIGELLA. NO RESULT WAS PROVIDED TO THE TREATING PHYSICIAN UNTIL SHIGELLA CONFIRMATION WAS OBTAINED FROM THE REFERENCE LABORATORY, AT WHICH TIME THE SHIGELLA RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS IMPROVING WITHOUT TREATMENT; THEREFORE, TREATMENT WAS WITHHELD BY THE PHYSICIAN UNTIL DISCHARGE FROM THE HOSPITAL. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMRIEUX 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.
Additional Manufacturer Narrative
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. TESTING INCLUDED: VITEK® 2 GN ID CARDS (CUSTOMER LOT AND RANDOM LOT), ID32E STRIP, API® 20E STRIP, AGGLUTINATION TEST FOR SHIGELLA. TESTING RESULTS: VITEK® 2 GN ID CARDS (CUSTOMER LOT AND RANDOM LOT) OBTAINED IDENTIFICATION OF ESCHERICHIA COLI. ID32E STRIP PROVIDED A RESULT OF ESCHERICHIA COLI. API 20E STRIP GAVE IDENTIFICATION OF ESCHERICHIA COLI. AGGLUTINATION TEST FOR SHIGELLA: NEGATIVE. BASED ON THE INVESTIGATION, THE IDENTIFICATION RESULT OF ESCHERICHIA COLI OBTAINED VIA THE VITEK® 2 GN ID IS CORRECT. THE VITEK® 2 GN ID TEST KIT IS PERFORMING IN ACCORDANCE WITH SPECIFICATIONS.