BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1791008 · Received July 29, 2010

    Report

    Report Number
    2027969-2010-01089
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 29, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT SELF TESTER ON ANTIBIOTICS HAD DISCREPANT RESULTS. DR HAS ORDERED LAB DRAWS UNTIL THE PT IS OFF ANTIBIOTICS WHICH ARE KNOWN TO INTERFERE WITH METER READINGS: (B)(6) 2010: INRATIO: 3.8, LAB: 2.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 NG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other