BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1110364 · Received August 14, 2008

    Report

    Report Number
    1823260-2008-05520
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT 2: MALE,MEDICAL HISTORY: ATRIAL FIBRILLATION. MEDICATIONS: COUMADIN: 2.5MG/5MG MWF; DATES UNKNOWN. PT 3: FEMALE, MEDICAL HISTORY: EMBOLISM, PULMONARY NSC, AT RISK FOR RECURRENT DEEP VEIN THROMBOSIS. MEDICATIONS: COUMADIN: 3MG/4.5MG MONDAY/FRIDAY; DATES UNKNOWN. PT 4: FEMALE, MEDICAL HISTORY: ATRIAL FIBRILLATION. MEDICATIONS COUMADIN 2.5MG/5MG MWF; DATES UNKNOWN. PT 5: FEMALE, MEDICAL HISTORY: VENOUS THROMBOSIS. MEDICATIONS: COUMADIN 7.5MG/11.5MG MWF; DATES UNKNOWN. PT 6: MALE, MEDICAL HISTORY: ATRIAL FIBRILLATION. MEDICATIONS: COUMADIN 5MG/DAY; DATES UNKNOWN.

    Description of Event or Problem · 1

    CALLER STATES DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/LABORATORY RESULTS WERE OBTAINED: 2.1 INR/1.66INR. 2.36INR/1.78 INR. 2.5 INR/1.85 INR. 2.5 INR./1.87 INR. 2.8 INR/2.09 INR. 2.3 INR/1.63 INR. NO TREATMENT INFO PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, STRIPS ARE UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS-GJS GJS ROCHE DIAGNOSTICS 20163831

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR COUMADIN 2.5MG/5MG MWF