BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITEK® 2 ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) AST-GN69 TEST KIT

    MDR report key: 5403292 · Received February 1, 2016

    Report

    Report Number
    1950204-2016-00013
    Event Type
    Death
    Date Received
    February 1, 2016
    Date of Event
    December 28, 2015
    Report Date
    January 20, 2016
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    N50510: S 82
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. TESTING INCLUDED: IDENTIFICATION OF THE ORGANISM WAS CONFIRMED AS ENTEROBACTER CLOACAE. VITEK 2 AST-GN69 (CUSTOMER LOT): OBTAINED A CEFTAZIDIME RESULT MIC <=1 (SUSCEPTIBLE). VITEK 2 AST-GN69 (RANDOM LOT): OBTAINED A CEFTAZIDIME RESULT MIC <=1 (SUSCEPTIBLE). AGAR DILUTION (AD): MIC = 1 (SUSCEPTIBLE). BROTH MICRO DILUTION (BMD): MIC < 0.5 (SUSCEPTIBLE). THE VITEK 2 AST-GN69 CARDS AND THE REFERENCE METHOD (AD) ARE IN AGREEMENT; THEREFORE THE CARDS ARE PERFORMING AS EXPECTED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A FALSE SUSCEPTIBLE CEFTAZIDIME RESULT FOR A ENTEROBACTER CLOACAE PATIENT ISOLATE (BLOOD) IN ASSOCIATION WITH THE VITEK 2 AST-GN69 TEST KIT. THE PATIENT LATER EXPIRED. (B)(6) 2015 - PATIENT ((B)(6) MALE) PRESENTED WITH NEUTROPENIA AND FEVER. PATIENT TREATED FOR NEUROBLASTOMA WITH MEROPENEM AND CEFTRIAXONE. (B)(6) 2015 - VITEK 2 TEST RESULTS INDICATE SUSCEPTIBILITY TO CEFTAZIDIME. PHYSICIAN REMOVED MEROPENEM THERAPY AND BEGAN CEFTAZIDIME THERAPY. (B)(6) 2015 - PHYSICIAN ADDED CIPROFLOXACIN THERAPY. (B)(6) 2015 - VITEK 2 TEST RESULTS INDICATE RESISTANCE TO CEFTAZIDIME. PHYSICIAN REMOVED CEFTAZIDIME THERAPY AND CONTINUED CIPROFLOXACIN THERAPY; ALSO ADDED MEROPENEM. (B)(6) 2015 - VITEK 2 TEST RESULTS CONTINUE TO INDICATE RESISTANCE TO CEFTAZIDIME. PATIENT WENT INTO SHOCK AND DIED. THE CUSTOMER STATED: THERE WAS NO DELAY IN, OR WITHHOLDING OF, PATIENT TREATMENT. THE PATIENT DID NOT UNDERGO ANY UNNECESSARY MEDICAL PROCEDURE DUE TO THE REPORTED EVENT. THE PHYSICIAN DOES NOT ALLEGE THE REPORTED EVENT CAUSED HIM/HER TO PROVIDE INCORRECT TREATMENT. IT DOES NOT APPEAR THE INSTRUMENT OR TEST MALFUNCTIONED. THE TEST RESULT WAS NOT INCORRECT. THE ORGANISM TESTED (B)(6) 2015 WAS EITHER A DIFFERENT STRAIN, OR THE ORGANISM BECAME RESISTANT DURING THE HOSPITAL STAY. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60892 VITEK® 2 ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) AST-GN69 TEST KIT AST-GN69 TEST KIT LON BIOMERIEUX, INC 589374040

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Death