BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2556510 · Received April 27, 2012

    Report

    Report Number
    2027969-2012-00598
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    March 27, 2012
    Report Date
    April 27, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH ANOTHER POINT-OF-CARE (POC) AND THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2012; INRATIO: 4.7; POC: 1.7. DATE: 04/02/2012; 7.4; LAB: 1.8. PT'S THERAPEUTIC RANGE: 2.0 - 2.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 272417

    Patients

    Seq Age Sex Outcome Treatment
    1 NI