BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 ANALYZER

    MDR report key: 1821920 · Received August 31, 2010

    Report

    Report Number
    1061932-2010-00132
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC BEFORE AND AFTER THE EVENT RECOVERED WITHIN RANGE. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND PERFORMED A PM (PREVENTIVE MAINTENANCE) AND VERIFIED THE INSTRUMENT'S PERFORMANCE. THE CUSTOMER OBSERVED RARE LARGE PLATELET FORMS AND RARE TINY PLATELET CLUMPS ON THE MANUAL PLATELET SCAN REVIEW. PER PRODUCT LABELING, PLATELET CLUMPS ARE A KNOWN INTERFERING SUBSTANCE FOR THE PLATELET PARAMETER. THE BCI INSTRUMENT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS LOW PLATELET (PLT) RESULTS GENERATED BY THE COULTER LH 780 ANALYZER FOR ONE PATIENT. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. MANUAL PLATELET ESTIMATES WERE PERFORMED WITH RESULTS THAT RANGED FROM 112,000 - 122,000 AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO DEATH, SERIOUS INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 780 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1