BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1913512 · Received November 24, 2010

    Report

    Report Number
    2027969-2010-02058
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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:" DATE: (B)(6) 2010, INRATIO: 3.8, LAB: 2.99. THERAPEUTIC RANGE: 2.0 TO 3.0. WHEN HE DID THE METER TEST, HE WARMED HIS HAND IN WASHING ROOM AND THEN WALKED BACK TO HIS CAR AND DID THE TEST. HIS HAND WAS NOT WARM WHEN HE PERFORMED THE TEST AND HE HAD TO MILK THE FINGER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1