BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2915412 · Received January 9, 2013

    Report

    Report Number
    2027969-2013-00020
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 9, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO2 METER COMPARED TO THE LAB FOR ONE PT. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 5.9, LAB: 1.3. CALLER DID NOT PROVIDE PT SPECIFIC OR TECHNIQUE INFORMATION BUT STATED THAT ALL OPERATORS ARE EXPERIENCED ON THE INRATIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12339 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 296416

    Patients

    Seq Age Sex Outcome Treatment
    1