BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2822778 · Received November 2, 2012

    Report

    Report Number
    2027969-2012-01589
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2012, INRATIO: 1.7. DATE: (B)(6) /2012, INRATIO: 1.2, 1.3, LAB: 1.9. LESS THAN 15 MIN. BETWEEN METER TEST AND LAB DRAW. PT SELF TESTER'S THERAPEUTIC RANGE IS 3.0-5.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 287167

    Patients

    Seq Age Sex Outcome Treatment
    1 OXYCODONE| SYNTHROID| COUMADIN