BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2123371 · Received June 10, 2011

    Report

    Report Number
    2027969-2011-01306
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 8, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 3.6, 3.9, 3.6, 3.4, 2.7. PATIENT'S HUSBAND CALLED IN BECAUSE, HE IS QUESTIONING METER RESULTS; (B)(6) 2011: INR=3.6; (B)(6) 2011: 5:35 PM INR=3.9, 5:40 PM INR=3.6, 7:35 PM INR=3.4; (B)(6) 2011: 7:20 PM INR=2.7. PATIENT'S THERAPEUTIC RANGE: 2.5-3.5. PATIENT NORMALLY TAKES 7 MG OF COUMADIN/NIGHT, HOWEVER, HER DOSE FOR (B)(6) HAS BEEN 5MG/NIGHT. DOSE WAS LOWERED BY MISTAKE BECAUSE, HER MEDICATION CASE IS FILLED FOR THE WEEK HE NOTICED ON (B)(6) THAT SHE WAS ONLY TAKING 5MG. NOT SURE OF WHEN SHE STARTED TAKING 5 MG BUT BELIEVES THAT IT WAS THE ENTIRE WEEK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1