BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1757275 · Received July 2, 2010

    Report

    Report Number
    2027969-2010-00894
    Event Type
    Malfunction
    Date Received
    July 2, 2010
    Date of Event
    June 15, 2010
    Report Date
    July 2, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 LAB. RESULTS AS FOLLOWS:" HISTORICALLY, PATIENT'S INR AROUND 2.9. THERAPEUTIC RANGE=2.5-3.5. FOLLOW UP FROM CUSTOMER ON (B)(6) 2010. SELF TEST PERFORMED ON STRIP LOT 225938 AND LOT 232886 USING DIFFERENT FINGERS. BOTH RESULTS WITHIN NORMAL RANGE AT 0.9. PATIENT BEING RETESTED (B)(6). PATIENT ON ANTIBIOTICS (AMOXICILLIN), WHICH SHE FINISHED YESTERDAY. NO KNOWN CHANGES IN MEDS, PRESCRIBED OVER THE COUNTER, LIFE STYLE, NO PROCEDURES, HOSPITAL STAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 225938

    Patients

    Seq Age Sex Outcome Treatment
    1