BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2961092 · Received January 30, 2013

    Report

    Report Number
    2027969-2013-00102
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO PRECISION RESULTS. RESULTS AS FOLLOWS: DATE (B)(6) 2013, INRATIO 1.1, RE-TEST 1.3, RE-TEST 2.2. INITIAL TEST AND 1ST RE-TET WERE PERFORMED MINUTES APART, 2ND RE-TST WAS PERFORMED ABOUT AN HOUR LATER. PATIENT SELF TESTER USED THE SAME FINGER FOR INITIAL 1ST AND 2ND RE-TEST. THERAPEUTIC RANGE: 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40503 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 297451A

    Patients

    Seq Age Sex Outcome Treatment
    1 (USUAL DOSE 7.5MG M/W/TH/F/SAT/SUN AND 5MG TU)| MEDICATION: WARFARIN