BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1853697 · Received September 29, 2010

    Report

    Report Number
    2027969-2010-01614
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METERS. RESULTS AS FOLLOWS: PT 1: DATE: (B)(6) 2010, INR: 1.0, 1.7. PT 2: DATE: (B)(6) 2010, INR: 0.7, 1.8. CUSTOMER RECEIVED DISCREPANT RESULTS ON A COUMADIN PT, BUT DID NOT HAVE RESULTS. THEY DECIDED TO TEST 2 NON-OAC PATIENTS USING THE SAME LOT ON TWO SEPARATE METERS (INRATIO & INRATIO 2). (RESULTS ABOVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232888

    Patients

    Seq Age Sex Outcome Treatment
    1 NI