BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2243514 · Received August 19, 2011

    Report

    Report Number
    2248721-2011-00104
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 25, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    PMA / PMN Number
    K961835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (CUVETTE LOT# D1K3H168). ACTUAL DEVICE INVOLVED IN INCIDENT EVALUATED. INSTRUMENT DEVICE HISTORY RECORD REVIEWED AND DEVICE HISTORY RECORD FOR CUVETTE LOT WAS ALSO REVIEWED. THERE ARE NO NCMRS AND INSTRUMENT AND CUVETTE MET ALL QC SPECS. THERE WERE NO COMPLAINT TRENDS OR RELATED CAPA/NCRS IDENTIFIED. RECORD EVAL COMPLETED. DEVICE OPERATED ACCORDING TO SPECS. COMPLAINT COULD NOT BE CONFIRMED. DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    A PT SELF-TESTER REPORTS THAT PROTIME MICROCOAGULATION SYSTEM WAS RUNNING LOWER THAN LAB REFERENCE. ON (B)(6) 2011, PROTIME GENERATED INR 2.0, LAB GENERATED INR 2.5. SHE HAD KNEE SURGERY (B)(6) 2011 AND STOPPED TAKING COUMADIN AND WAS ON LOVENOX. SHE HAD SINCE STOPPED TAKING LOVENOX (LAST DOSE 5 WEEKS PRIOR) AND WAS BACK ON COUMADIN. HER PHYSICIAN HAD BEEN INCREASING HER COUMADIN DOSES BASED ON THE PROTIME RESULT. 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 ON WHO HAVE AN ABNORMAL RESPONSE TO HEPARIN". PT'S THERAPEUTIC RANGE IS INR 2.5 TO 3.0. NO ADVERSE EVENT (S) REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR COUMADIN| LOVENOX