BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2941246 · Received January 18, 2013

    Report

    Report Number
    2027969-2013-00070
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE REFERENCE. RESULTS AS FOLLOWS:" DATE: (B)(6) 2013, PST INRATIO: 2.3, MD INRATIO: 1.6. PT SELF TESTER'S INRATIO INR=2.3; DOCTOR'S INRATIO INR=1.6; SAME LOT STRIPS AND SAME FINGERSTICK SITE USED. PT SELF TESTER'S METER PERFORMED FIRST THEN THE SECOND DROP OF BLOOD WAS APPLIED TO THE MD'S METER. THERAPEUTIC RANGE: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28419 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 284732

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| BEEN ON FOR A WHILE WITH NO RECENT DOSAGE CHANGES.| PAIN MEDICATIONS, NAME NOT PROVIDED, BUT PT HAS