BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3023112 · Received February 26, 2013

    Report

    Report Number
    2027969-2013-00167
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO METER COMPARED TO THE LAB FOR ONE PT. COMPLAINT SUMMARY: DATE: (B)(6) 2013; INRATIO: 1.7; LAB: 4.2. PT'S THERAPEUTIC RANGE IS UNK. HOME HEALTH NURSE COULD NOT PROVIDE ANY INFO REGARDING SAMPLE COLLECTION TECHNIQUE OR PT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83143 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100139

    Patients

    Seq Age Sex Outcome Treatment
    1