BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2193268 · Received July 13, 2011

    Report

    Report Number
    2248721-2011-00085
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 15, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    PMA / PMN Number
    K961835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS BEEN REQUESTED. NO PRODUCT RETURNED. CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT SELF-TESTER REPORTS DISCREPANT RESULTS BETWEEN PROTIME MICROCOAGULATION SYSTEM AND LAB. SHE IS RECOVERING FROM A RECENT UNSPECIFIED SURGERY AND TAKING LOVENOX AS A BRIDGE THERAPY. SHE STOPPED TAKING COUMADIN FOR THE SURGERY AND IS CURRENTLY ON A LOWER DOSE OF COUMADIN WITH THE LOVENOX. ON (B)(6) 2011, SHE GENERATED INR 1.8. THE HOSPITAL LAB GENERATED INR 3.2 A HALF HOUR LATER. LOVENOX IS A TRADE NAME OF LOW MOLECULAR WEIGHT HEPARIN. THE PROTIME PACKAGE INSERT INDICATES IN THE "LIMITATIONS" SECTION THAT "RESULTS MAY BE AFFECTED IN PTS RECEIVING HEPARIN OR WHO HAVE AN ABNORMAL RESPONSE TO HEPARIN." PT'S THERAPEUTIC RANGE INR 2.5 - 3.5. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM GJS INTERNATIONAL TECHNIDYNE CORP. PROTIMEPRO

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| LOVENOX