BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSPIN MP

    MDR report key: 4030386 · Received July 29, 2014

    Report

    Report Number
    2023446-2014-00095
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    IRIS DIAGNOSTICS
    Product Code
    GKG
    PMA / PMN Number
    K920759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A ROTOR BROKE APART, BUT THE CONTENTS WERE CONTAINED WITHIN THE CENTRIFUGE. NO ONE WAS EXPOSED OR HAD TO BE TREATED. NO INJURIES OR LOSS OF PATIENT SAMPLES WERE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE CENTRIFUGE ROTOR BROKE APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442554 STATSPIN MP STATSPIN CENTRIFUGE GKG IRIS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1