BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3082581 · Received April 24, 2013

    Report

    Report Number
    2027969-2013-00334
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ALERE SAN DIEGO INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: PATIENT'S THERAPEUTIC RANGE WAS 2-3 AND RESULTS HAD BEEN AROUND 2.9-3.0 INR. PATIENT JUST WOKE UP ONE DAY AND HAD A BLEEDING INCIDENT. PATIENT WAS HOSPITALIZED; PHYSICIAN DID NOT KNOW WHAT CAUSED THE BLEEDING. PATIENT WAS GIVEN A NEW THERAPEUTIC RANGE OF 1.8-2.5. PATIENT SELF TESTER RETURNED FROM HOSPITALIZATION FROM BLEEDING INCIDENT AND TESTED ON THE INRATIO METER. DATE: (B)(6) 2013, INRATIO: >7.5, LAB: 2.1. PATIENT WAS UNABLE TO PROVIDE INFORMATION REGARDING MEDICATIONS OR MEDICAL CONDITION. PATIENT SELF TESTER STATES SHE MAY HAVE TOUCHED THE STRIP WHEN APPLYING SAMPLE TO THE INRATIO STRIP, AND LEFT AN OLD STRIP IN THE METER FOR AN UNSPECIFIED AMOUNT OF TIME. PATIENT WAS TAKING AN ANTIBIOTIC FOR A URINARY INFECTION ONE WEEK BEFORE TESTING ON THE INRATIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177293 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC. 100071 301621

    Patients

    Seq Age Sex Outcome Treatment
    1