BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2000489 · Received January 31, 2011

    Report

    Report Number
    2027969-2011-00220
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 0.8, RE-TEST: 1.6. TESTING WAS DONE WITHIN 20 MINUTES OF EACH OTHER. PT IS BEING MONITORED BECAUSE SHE IS POST-OP. SHE HAD KNEE SURGERY A FEW DAYS PRIOR TO (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO 100139 239277

    Patients

    Seq Age Sex Outcome Treatment
    1