BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2419925 · Received January 18, 2012

    Report

    Report Number
    1061932-2012-00110
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    December 23, 2011
    Report Date
    December 23, 2011
    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

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE COULTER LH 750 HEMATOLOGY ANALYZER WAS GENERATING ''RETIC LS OFFFSET HIGH'' (RETIC LASER OFFSET HIGH) ERRORS AND OVERANGE RESULTS. BEC CUSTOMER TECHNICAL SUPPORT ADVISED THE CUSTOMER TO CHECK THE RETIC CLEARING SOLUTION PUMP (PM 6). CUSTOMER REPORTED THAT ONE OF THE TUBING AT PM6 WAS LOOSE. CUSTOMER REPORTED THAT RECONNECTING THE TUBING RESOLVED THE ISSUE. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1