BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2150392 · Received June 8, 2011

    Report

    Report Number
    2027969-2011-01283
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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) 2011, INRATIO: 4.0, LAB: 1.3. NO PATIENT INFORMATION PROVIDED BY CUSTOMER. CALLER REPORTS RUNNING SELF TEST AND RESULTING INR OF 1.1. NO FURTHER TROUBLESHOOTING WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 251115

    Patients

    Seq Age Sex Outcome Treatment
    1