BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUMATRAK PROTIME TEST SYSTEM

    MDR report key: 31447 · Received January 6, 1995

    Report

    Report Number
    1054435-1994-00006
    Event Type
    Malfunction
    Date Received
    January 6, 1995
    Date of Event
    December 15, 1994
    Report Date
    January 5, 1995
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A MEDICAL TECHNOLOGIST REPORTED THAT A PT, WITH A HISTORY OF END-STAGE CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HAS BEEN TAKING COUMADIN BECAUSE OF A MECHANICAL AORTIC VALVE. PROTIMES (PROTHROMBIN TIMES, PTS) HAVE BEEN FLUCTUATING SINCE 8/94 AND WERE THEREFORE BEING MONITORED FREQUENTLY. THE PHYSICIAN FELT THAT THE PT WAS EXPERIENCING DRUG INTERACTIONS BECAUSE OF THE NUMBER OF MEDICATIONS HE WAS RECEIVING. ON 12/15/94, ON A COUMADIN REGIMEN OF 7.5 MG QD, THE RPTR NOTED THAT THE PT HAD BRUISES ALL OVER HIS ARMS. PT ON THE TEST SYSTEM MONITOR WAS 16.5 SECONDS. THE PHYSICIAN QUESTIONED THE RESULTS, AND THE TEST WAS REPEATED THREE MORE TIMES. RESULTS WERE 39, 14, AND 15 SECONDS. A SPECIMEN WAS SENT TO AN OUTSIDE LAB WHERE PT WAS REPORTED AS 48.4 SECONDS. THE RPTR'S SUPERVISOR INDICATED THAT SHE HAD CONFIDENCE IN THE MONITOR. COUMADIN WAS HELD ON 16- AND 17-DEC-94 AND WAS RESUMED AT 5 MG QD ON 18-DEC-94. A SECOND MONITOR WAS SENT TO THE PHYSICIAN'S OFFICE. ON 12/19/94, PT WAS 16 SECONDS ON THE ORIGINAL MONITOR, 27.2 SECONDS ON THE SECOND MONITOR, AND 23 SECONDS ACCORDING TO THE OUTSIDE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUMATRAK PROTIME TEST SYSTEM IN VITRO HEMATOLOGY DEVICE GJS BOEHRINGER MANNHEIM CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other