BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 2507503 · Received March 28, 2012

    Report

    Report Number
    1061932-2012-01021
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 29, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THEIR COULTER ACT DIFF ANALYZER GAVE ABNORMALLY LOW HEMOGLOBIN (HGB) RESULTS ON FOUR PEDIATRIC FINGER STICK SAMPLES ON THREE DIFFERENT DAYS COMPARED TO VENIPUNCTURE DRAWN RESULTS WITHOUT INSTRUMENT GENERATED FLAGS. ERRONEOUS RESULTS WERE NOT REPORTED OUT. THE PATIENTS WERE REDRAWN VIA VENIPUNCTURE AND RUN ON THE ACT DIFF AND THEN SENT TO A REFERENCE LAB WHOSE RESULTS WERE NOT AVAILABLE BUT MATCHED THE ACT DIFF VENIPUNCTURE RESULTS AND CONSIDERED CORRECT. THIS REPORT DOCUMENTS THE RESULTS GENERATED ON (B)(6) 2012 FOR PATIENT 2. THE ADDITIONAL PATIENTS AND DATES THE ERRONEOUS RESULTS WERE GENERATED ARE DOCUMENTED IN SEPARATE REPORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1