BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3772001 · Received December 31, 2013

    Report

    Report Number
    2027969-2013-01148
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    December 2, 2013
    Report Date
    December 20, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) 2013, INRATIO2: 5.7, 4.2, LAB: 10.3. TIME BETWEEN INITIAL INRATIO VALUE (5.7) AND LAB WAS 8 HOURS; BETWEEN LAB AND SECOND INRATIO TEST (4.2) WAS 10 MINUTES. HISTORIC INRATIO RESULTS: (B)(6) INRATIO INR=6.3, (B)(6) INRATIO INR=6.0, COUMADIN WITHHELD 3 DAYS, (B)(6) INRATIO INR=3.0, COUMADIN DOSAGE RESUMED, (B)(6) INRATIO INR=6.6, COUMADIN WITHHELD 3 DAYS. THERAPEUTIC RANGE: 2.0-3/0. CALLER STATED THAT METER IS PLACED ON TOP OF THE STRIP BOX WHICH IS ON THE TABLE. PT SELF TESTER IS MILKING FINGER AFTER FINGERSTICK. PT WAS NOT HOSPITALIZED BUT HAS HAD MEDICATION WITHHELD BASED SOLELY ON INRATIO RESULTS ON 1(B)(6). TECHNICAL SERVICE REP CONFIRMED THAT PT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682987 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 329655

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN (1/2 - 1 MG DAILY)