BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2912549 · Received January 13, 2013

    Report

    Report Number
    1061932-2013-00017
    Event Type
    Malfunction
    Date Received
    January 13, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PROBE WIPE ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT A SMALL AMOUNT OF CLENZ WAS DRIPPING FROM THE MANUAL PROBE AREA OF THE COULTER LH 750 HEMATOLOGY ANALYZER (LH 750). CUSTOMER REPORTED THE LEAK WAS CONTAINED IN THE INSTRUMENT. CUSTOMER REPORTED PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO EVALUATE THE INSTRUMENT. THE FSE FOUND THE WASTE TRUCK ON THE PROBE WIPE ASSEMBLY WAS LOOSE AND WAS GETTING CAUGHT ON THE BASE OF THE PROBE WIPE ASSEMBLY CAUSING THE LH 750 NOT TO DRAIN PROPERLY. THE FSE TIGHTENED THE WASTE TRUCK AND RESOLVED THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19452 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1