BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSPIN MP

    MDR report key: 4102704 · Received August 28, 2014

    Report

    Report Number
    2023446-2014-00139
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    GKG
    PMA / PMN Number
    K920759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INADEQUATE SPINNING OF SAMPLES WAS REPORTED FOR THE CENTRIFUGE. CUSTOMER HAD TO SPIN MULTIPLE TIMES TO SEPARATE THE TUBES. NO CHANGE TO PT MANAGEMENT OR ERRONEOUS RESULTS WERE GENERATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UNIT WAS NOT SPINNING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526669 STATSPIN MP STATSPIN CENTRIFUGE GKG IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1