BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3020946 · Received March 19, 2013

    Report

    Report Number
    2027969-2013-00231
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN AFTER OBSERVING VARYING RESULTS ON 1 PT, 2 METERS AND 1 LOT. INRATIO #1 SN: (B)(4), INR = 0.9. INRATIO #2 SN: (B)(4), INR = 2.0. TWO MINS BETWEEN EACH TEST. PT'S THERAPEUTIC RANGE 2.0 - 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113250 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 300661

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN