BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2913066 · Received January 8, 2013

    Report

    Report Number
    2027969-2013-00014
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 8, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 REFERENCE. RESULTS AS FOLLOWS:" DATE: (B)(6) 2012, PT'S INRATIO: 1.0, DR'S INRATIO: 3.4, LAB: 3.4. THERAPEUTIC RANGE: 2.0-3.0. TIME BETWEEN TESTS WAS IMMEDIATE. NURSE REPORTING MULTIPLE DISCREPANCIES ON BEHALF OF PT ACROSS MULTIPLE LOTS ALTHOUGH DATA AND LOT NUMBERS COULD ONLY BE PROVIDED FOR ONE INSTANCE. A NEW FINGER WAS USED FOR EACH INRATIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9249 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 287169

    Patients

    Seq Age Sex Outcome Treatment
    1 SOTALOL| COUMADIN: DOSAGE UNK, NO RECENT CHANGES NOTED