BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 1772718 · Received July 26, 2010

    Report

    Report Number
    2248721-2010-00114
    Event Type
    Death
    Date Received
    July 26, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 26, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). COMPLAINT IS STILL BEING EVALUATED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS PATIENT ENROLLED IN THE (B) (4) CLINICAL TRIAL DEAT,H DUE TO "FATAL OVERDOSE". PATIENT WAS ADMITTED TO THE HOSPITAL AND TESTED IN THE LAB AND HAD AN INR >8. CUSTOMER STATED THAT THE DEATH WAS NOT IN ANY WAY RELATED TO THE POC DEVICE. PATIENT PURPORTEDLY INADVERTENTLY OVERDOSED BY TAKING 5MG/DOSE INSTEAD OF 1MG/DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM PROTIME INSTRUMENT GKP INTERNATIONAL TECHNIDYNE CORP. PROPH110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK