BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT

    MDR report key: 5066992 · Received September 10, 2015

    Report

    Report Number
    1950204-2015-00026
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Report Date
    August 28, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    JTO
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. 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.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) RECEIVED CAP RESULTS WHERE THE ISOLATE SHOULD HAVE BEEN IDENTIFIED AS ACINETOBACTER IWOFFII; HOWEVER, RESULTS FROM VITEK 2 GN ID TEST KIT, (REF 21341) WERE IDENTIFIED AS ACINETOBACTER BAUMANII. THE CUSTOMER PERFORMED THE TEST USING TWO DIFFERENT LOTS OF VITEK 2 GN ID TEST KIT (LOTS 241337120, MANUF. 08MAR15, EXPIRY 07MAR16 AND 241344640, MANUF. 22MAY15, EXPIRY 21MAY16), AND OBTAINED THE SAME RESULTS. 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
    598894 VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD JTO BIOMERIEUX, INC 241337120

    Patients

    Seq Age Sex Outcome Treatment
    1