BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T 8/10 ANALYZER

    MDR report key: 2082331 · Received May 9, 2011

    Report

    Report Number
    1061932-2011-00397
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE COLLECTION DETAILS WERE NOT PROVIDED. QC WAS RUN BEFORE AND AFTER THIS EVENT AND RESULTS WERE WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A FULL DECONTAMINATION, INSPECTION AND VERIFICATION OF THE INSTRUMENT. ALL RESULTS WERE WITHIN SPECIFICATIONS AND VALIDATION WAS COMPLETED. . THE ROOT CAUSE BASED ON DATA PROVIDED IS MOST LIKELY RELATED TO SAMPLE MIXING. THE PATIENT'S RESULTS ARE INDICATIVE OF INADEQUATE MIXING. PER BCI LABELING: "WHEN WBC AND PLT RARE TOO HIGH OR LOW, HGB AND RBC ARE OPPOSITE, TOO LOW OR HIGH. SAMPLE WAS NOT MIXED ADEQUATELY BEFORE ASPIRATION. REMIX SAMPLE AND CYCLE AGAIN."

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) REGARDING INCORRECT LOW WHITE BLOOD COUNT (WBC), PLATELET (PLT) AND HIGH RED BLOOD COUNT (RBC), HEMOGLOBIN (HGB), AND HEMATOCRIT (HCT) RESULTS, WITHOUT INSTRUMENT GENERATED FLAGS, GENERATED BY THE COULTER ACT 8/10 ANALYZER FOR ONE PATIENT. THE RESULTS WERE REPORTED OUT OF THE LAB. THE SAME PATIENT WAS REDRAWN 2 DAYS LATER AND RUN ON THIS AND ON A DIFFERENT INSTRUMENT WHERE BOTH INSTRUMENTS GAVE RESULTS THAT WERE CONSIDERED CORRECT. THE ORIGINAL SPECIMEN WAS THEN RE-TESTED ON THE DIFFERENT INSTRUMENT AND OBTAINED RESULTS CORRELATED WITH THE SECOND SAMPLE. A CORRECTED REPORT WAS ISSUED. THERE WAS NO DEATH, SERIOUS INJURY, OR EFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® AC*T 8/10 ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. AC* T 8/10 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1