BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 3933564 · Received July 15, 2014

    Report

    Report Number
    1061932-2014-01613
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND ADJUSTED THE HEMOGLOBIN VOLTAGE TO RESOLVE THE ERROR CONDITION OF VOTEOUTS FOR THE HEMOGLOBIN PARAMETER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERROR CONDITION OF VOTEOUTS (NON-NUMERIC RESULTS) FOR THE HEMOGLOBIN PARAMETER AFTER CALIBRATION WAS PERFORMED ON THE COULTER ACT DIFF 2 ANALYZER. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414338 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1