BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 2950445 · Received February 5, 2013

    Report

    Report Number
    2027969-2013-00113
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 20, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    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, INRATIO: 5.2, 4.1, 3.6, LAB: 6.6. TESTING WAS REPORTED AS PERFORMED SIMULTANEOUSLY. CUSTOMER DID NOT KNOW THE PATIENT'S THERAPEUTIC RANGE. CUSTOMER ALLEGED THEY OBSERVED DISCREPANCIES ON THREE PATIENTS USING ONE LOT OF STRIPS ON THE SAME METER. CUSTOMER WAS ABLE TO PROVIDE INFORMATION FOR ONLY ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48148 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 291558

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN