VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Sep 18, 2015
Report 1950204-2015-00037 · MDR key 5087271
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), LOT 241350340). A SHIGELLA SONNEI ORGANISM MISIDENTIFIED AS ENTEROBACTER GERGOVIAE. WHEN THE TEST IS REPEATED USING A DIFFERENT VITEK 2 GN ID CARD LOT (241349540) AND A SHORT BIOCHEMICAL PANEL (TSI, LI, MOT, UREA), THE SAMPLE RESULT IS SHIGELLA SONNEI. AT BIOMERIEUX REQUEST, THE CUSTOMER REPEATED TESTING USING BOTH LOT NUMBERS OF VITEK 2 GN ID CARD AND OBTAINED RESULTS OF SHIGELLA SONNEI. 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.
Additional Manufacturer Narrative
INTERNAL INVESTIGATION WAS CONDUCTED. THE SUBMITTED PATIENT ISOLATE WAS SUBCULTURED TO TSAB AND MACCONKEY (MAC) AGAR, AND TESTING FROM EACH MEDIA INCLUDED: ONE (1) VITEK® 2 GN ID CARD SUBMITTED BY THE CUSTOMER. ONE (1) VITEK® 2 GN ID CARD FROM INTERNAL RETAINS (CUSTOMER LOT). TWO (2) VITEK® 2 GN ID CARDS FROM THE 2ND LOT TESTED BY THE CUSTOMER (INTERNAL RETAINS). TWO (2) VITEK® 2 GN ID CARDS FROM A RANDOM LOT. THEREFORE, FROM EACH MEDIA A TOTAL OF SIX (6) VITEK® 2 GN ID CARDS WERE SET UP AND TESTED; AN EXCELLENT IDENTIFICATION OF SHIGELLA SONNEI WAS OBTAINED FROM ALL GN ID CARDS TESTED. THE ORGANISM WAS ALSO TESTED ON THE API 20E AND AN IDENTIFICATION OF SHIGELLA SONNEI WAS OBTAINED. BASED ON THE RESULTS OF THE INVESTIGATION, THE VITEK® 2 GN ID CARDS ARE PERFORMING AS EXPECTED.