BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH750

    MDR report key: 1781457 · Received August 3, 2010

    Report

    Report Number
    1061932-2010-00099
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN LIMITS BEFORE THE EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. RAW DATA WAS REQUESTED BUT NOT PROVIDED. BECKMAN COULTER INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER INC. SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF THE INSTRUMENT RESULTS. THE ROOT CAUSE FOR THE MISSED BLAST FLAGGING IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) STATING THAT THE COULTER LH 750 ANALYZER DID NOT FLAG A SPECIFIC PATIENT SAMPLE CONTAINING BLASTS. MANUAL DIFFERENTIAL REVIEW INDICATED 60% BLASTS. THE COMPLETE DIFFERENTIAL COUNT WAS NOT PROVIDED, ONLY THE BLAST RESULTS WERE RECEIVED. THE CUSTOMER REPORTED OUT THE MANUAL DIFFERENTIAL RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO DEATH OR INJURY AND PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1