BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2? ANALYZER

    MDR report key: 3212107 · Received July 8, 2013

    Report

    Report Number
    1061932-2013-01422
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUES THROUGH SYSTEM TROUBLESHOOTING VIA THE TELEPHONE. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308830 COULTER® ACT DIFF 2? ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1