BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABX MICROS 60 IM2

    MDR report key: 2852975 · Received November 9, 2012

    Report

    Report Number
    2086725-2012-00002
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 9, 2012
    Manufacturer
    HORIBA ABX SAS
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY WAS CONTACTED SEVERAL TIMES DURING THE TIME FRAME OF (B)(6) 2012. THE RECORDED MESSAGE ON THE ANSWERING MACHINE INDICATES THAT DUE TO SEVERE WATER DAMAGE FROM THE HURRICANE, THE FACILITY IS CLOSED AT THIS TIME. THIS MDR IS BEING SUBMITTED AS A CONSERVATIVE MEASURE BASED ON THE FACT THAT THERE IS A CORRELATION BETWEEN HEMOGLOBIN VALUES AND HEMATOCRIT THAT COULD IMPACT PT CARE AND RESULT IN SERIOUS INJURY. HORIBA CONTINUES TO INVESTIGATE THE REPORTED EVENT AND WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING DISCREPANT CBC RESULTS (OUT OF CONTROLS RESULTS FOR HGB AND WBC) ON MICROS 50 HEMATOLOGY ANALYZER. THE INSTRUMENT GENERATED A FLAG FOR WBC. THE FIELD SERVICE ENGINEER WAS DISPATCHED. IT IS UNCERTAIN, AT THIS TIME, IF THE RESULTS WERE REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABX MICROS 60 IM2 HEMATOLOGY ANALYZER GKZ HORIBA ABX SAS M60CSB110EN04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other