BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2992928 · Received February 28, 2013

    Report

    Report Number
    2027969-2013-00171
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: PATIENT: 3; INRATIO: 2.8; HOSPITAL LAB: 1.8. TIME BETWEEN TESTING: UNK. NO PT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87278 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139

    Patients

    Seq Age Sex Outcome Treatment
    1