VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Jan 12, 2016
Report 1950204-2016-00006 · MDR key 5361529
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. TESTING INCLUDED ONE (1) VITEK® 2 GN ID CARD FROM A LOT MANUFACTURED CLOSE TO THE LOT USED BY THE CUSTOMER AND ONE (1) CARD FROM A RANDOM LOT. API® 20E TEST WAS ALSO PERFORMED. THE VITEK® 2 GN ID CARDS PROVIDED ORGANISM IDENTIFICATION OF KLEBSIELLA PNEUMONIAE, MATCHING THE CUSTOMER RESULT. THE API® 20E GAVE AN IDENTIFICATION OF ENTEROBACTER AEROGENES. THE INVESTIGATION CONCLUDED THAT THE PATIENT ISOLATE IS AN ATYPICAL STRAIN FOR THE VITEK® 2 SYSTEM PHENOTYPIC AST TESTING METHOD. GENETIC MEASUREMENT TECHNIQUES AND NON-AUTOMATED METHODS SUCH AS API® AND DISC DIFFUSION ARE MORE CONDUCIVE TO TESTING ORGANISMS EXHIBITING THIS BEHAVIOR.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN THE UNITED STATES REPORTED THE VITEK 2 GRAM-NEGATIVE (GN) ID TEST KIT MISIDENTIFIED A URINE SAMPLE AS KLEBSIELLA PNEUMONIAE. THE ISOLATE WAS SENT TO A STATE LAB BECAUSE OF POSSIBLE CRE (CARBAPENEM-RESISTANT ENTEROBACTERIACEAE). A RESULT OF ENTEROBACTER AEROGENES WAS OBTAINED VIA MALDI METHOD. UPON RECEIVING THE DISCREPANT MALDI RESULT AS COMPARED TO THE VITEK 2 GN ID RESULT, THE CUSTOMER PERFORMED TESTING OF THE ISOLATE VIA APITRIP; THE RESULT WAS ENTEROBACTER AEROGENES. RETESTING USING THE VITEK 2 GN ID CARD AGAIN PROVIDED THE IDENTIFICATION OF KLEBSIELLA PNEUMONIAE. THE CUSTOMER INDICATED THE ISOLATE WAS MUCOID BUT STILL WENT INTO A HOMOGENOUS SUSPENSION. 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.