BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH750

    MDR report key: 1934920 · Received December 21, 2010

    Report

    Report Number
    1061932-2010-00300
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES OF THE BARCODE ARE NOT AVAILABLE. ON (B)(4) 2010 SERVICE REPLACED THE BARCODE SCANNER RIBBON CABLE. ON (B)(4) 2010, SERVICE REPLACED THE BARCODE SCANNER ASSEMBLY. ON (B)(4) 2010, SERVICE ALIGNED BARCODE SCANNER. ON (B)(4) 2010 SERVICE REPLACED DILUTER 1 BOARD AND DILUTER CPU BOARD. A CLEAR ROOT CAUSE IS UNKNOWN FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO MISREAD SAMPLE IDS FOR FOUR SPECIMENS (4) ON THE COULTER LH 750 ANALYZER. THE RESULTS GENERATED A NO MATCH ERROR THE ANALYZER MISPLACED 2 FROM THE SAMPLE ID WITH A Q. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER KNEW THE SPECIMENS WERE MISIDENTIFIED BECAUSE THEY WERE CHECKING THE BAR CODE LABELS AGAINST THE INSTRUMENT PRINTOUTS. NO PATIENT DEMOGRAPHICS WERE ASSIGNED. NO IMPACT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ® LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1