BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

    MDR report key: 5062023 · Received September 8, 2015

    Report

    Report Number
    1950204-2015-00025
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Report Date
    August 18, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN THE UNITED STATES REPORTED A DISCREPANT ORGANISM IDENTIFICATION IN ASSOCIATION WITH A CAP SURVEY ORGANISM (D-08 ACINETOBACTER LWOFFII) AND THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION TEST KIT (CARD). THE ORGANISM WAS REPORTED AS ACINETOBACTER BAUMANII BY THE HOSPITAL LABORATORY. THIS RESULT WAS OBTAINED BY THE CUSTOMER USING TWO (2) DIFFERENT CARD LOTS. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED USING THE SAME CAP SURVEY ORGANISM FROM INTERNAL STOCK. THE ORGANISM WAS SUBCULTURED, AND TESTING INCLUDED ONE (1) GN ID CARD FROM EACH CUSTOMER LOT AND ONE (1) CARD FROM TWO (2) RANDOM LOTS. API® 20NE WAS ALSO PERFORMED. FOR ONE (1) OF THE CUSTOMER LOTS (241337120) AND THE TWO (2) RANDOM LOTS, A LOW DISCRIMINATION CALL OF ACINETOBACTER LWOFFII / MORAXELLA GROUP WAS OBTAINED. SINCE ACINETOBACTER LWOFFII IS PRESENTED AS A POSSIBLE ORGANISM, THE RESULTS ARE ACCEPTABLE FOR VITEK 2 TESTING. FOR THE OTHER CUSTOMER LOT (241344640), AN IDENTIFICATION OF MORAXELLA GROUP WAS OBTAINED. THE API 20NE GAVE A GOOD IDENTIFICATION (B)(4) OF A. LWOFFII . DUE TO THE DUPLICATION OF THE CUSTOMER RESULT FOR GN ID CARD LOT 241344640, EVALUATION OF MANUFACTURING AND QC BATCH RECORDS WAS PERFORMED. THE EVALUATION INDICATED THE LOT PASSED ON INITIAL TESTING AND PERFORMED IN ACCORDANCE WITH SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER RECEIVED CAP RESULTS WHERE ISOLATE SHOULD HAVE BEEN IDENTIFIED AS ACINETOBACTER IWOFFII HOWEVER, RESULTS FROM VITEK 2 GN ID TEST KIT, (REF (B)(4)) WERE IDENTIFIED AS ACINETOBACTER BAUMANII 99% TWO TIMES. 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. LAB REPORTS AND ISOLATE SUBMITTAL HAVE BEEN REQUESTED FROM THE CUSTOMER. BIOMERIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593046 VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD JTO BIOMERIEUX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1