BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABX MICROS 60 HEMATOLOGY ANALYZER

    MDR report key: 2922576 · Received January 15, 2013

    Report

    Report Number
    2086725-2013-00007
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    HORIBA ABX, SAS
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, CUSTOMER REPORTED TO HORIBA MEDICAL (HORIBA) THAT THE QC RAN ON THE ABM MICROS 60 HEMATOLOGY ANALYZER (MICROS 60) WERE OUT OF ESTABLISHED RANGES FOR THE WHITE BLOOD CELL DIFFERENTIAL ANALYTES ON THE LOW AND NORMAL LEVELS. HORIBA TECHNICAL SUPPORT (TS) ASSISTED THE CUSTOMER VIA TELEPHONE. TS INSTRUCTED THE CUSTOMER TO CHECK THE EXPIRATION DATING ON THE REAGENTS BEING USED. CUSTOMER REPORTED THE REAGENTS WERE BEYOND THEIR ON-BOARD EXPIRATION DATING AND NEEDLE TO BE REPLACED. ON (B)(6) 2012, CUSTOMER REPORTED THAT THEY REPLACED THE EXPIRED REAGENT, QC NOW PASSING, AND INSTRUMENT PERFORMING SATISFACTORILY. CUSTOMER DID NOT PROVIDE ANY INFO ON WHETHER RESULTS HAD BEEN REPORTED OUTSIDE THE LABORATORY DURING THE USE OF THESE EXPIRED REAGENTS. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY RESULTING MEDICAL INTERVENTION OR PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22537 ABX MICROS 60 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ HORIBA ABX, SAS

    Patients

    Seq Age Sex Outcome Treatment
    1