BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF2 ANALYZER

    MDR report key: 1930181 · Received December 16, 2010

    Report

    Report Number
    1061932-2010-00287
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTROLS PROCESSED BEFORE AND AFTER THE EVENT, AND WERE WITHIN ASSAY LIMITS. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED FLUID FILTERS AND PERFORMED MISCELLANEOUS TUNING. FSE ALSO BLEACHED ISOLATION CHAMBER, RAN CONTROLS AND VERIFIED THE INSTRUMENT'S PERFORMANCE. THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER ACT DIFF 2 INSTRUMENT GENERATED ERRONEOUS LOW WBC, RBC, HCT AND PLT RESULTS FOR TWO PATIENT SAMPLES. THE CUSTOMER DETERMINED THAT THE RESULTS WERE NOT MATCHING RESULTS FROM PATIENT'S PREVIOUS HISTORY AND SENT THE PATIENTS TO REFERENCE LAB FOR TESTING. REFERENCE LAB RESULTS WERE HIGHER WHICH THE LAB CONSIDERS CORRECT. (REFERENCE LAB RESULTS WERE REQUESTED, BUT NOT PROVIDED) THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. ACT DIFF2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1