BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUMATRAK PROTIME TEST SYSTEM

    MDR report key: 19386 · Received October 12, 1994

    Report

    Report Number
    1216602-1994-00028
    Event Type
    Injury
    Date Received
    October 12, 1994
    Date of Event
    September 26, 1994
    Report Date
    October 5, 1994
    Manufacturer
    BOEHRINGER MANNHIEM CORPORATION-FREEMONT
    Product Code
    LOQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MEDICAL TECHNOLOGIST REPORTED TT A PT HAD BEEN TAKING COUMADIN 7.5 MG QD BECAUSE OF A HISTORY OF DVT (DEEP VEIN THROMBOSIS) AND PE (PULMONARY EMBOLISM). ON 26-SEP-94, HER PT (PROTHROMBIN TIME) WAS 16.7. SECONDS USING A COUMATRAX PROTIME TEST SYSTEM (COUMATRAK MONITOR;THROMBOPLASTIN CARTRIDGE IN THE PHYSICIAN'S OFFICE. LATER THAT DAY, SHE WAS ADMITTED TOTHE HOSPITAL WITH A CVA (CEREBROVASCULAR ACCIDENT) DESCRIBED AS HEMORRHAGIC. PT WAS 30 SECONDS WHEN TESTED IN THE HOSPITAL. THIS SECOND TEST WAS DONE APPROX. ONE HR AFTER THE FIRST. THE HOSPITAL WAS USING A NEW THROMBOPPLASTIN WITH AN ISI (INTERNATIONAL SENSIVITY INDEX) OF 2.02. THE COUMATRAX MONITOR WAS BEING OPERATED BY THE MEDICAL TECHNOLOGIST. PROPER TECHNIQUES AND USE OF CONTROLS CONFIRMED. THE COUMATRAX MONITOR WILL BE RETURNED TO THE MFG. FOR EEVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUMATRAK PROTIME TEST SYSTEM IN VITRO HEMATOLOGY DEVICE LOQ BOEHRINGER MANNHIEM CORPORATION-FREEMONT NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R