BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2030196 · Received March 21, 2011

    Report

    Report Number
    2027969-2011-00562
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011; INRATIO: 3.9; LAB: 1.6. CALLER STATED THAT VENOUS BLOOD WAS USED FOR THE INRATIO TEST, AND THEN SENT THE BLOOD TO THE LAB. CALLER TESTED ANOTHER PT THAT WAS EVALUATED AS NON-REPORTABLE COMPLIANT IN ANOTHER CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 239279

    Patients

    Seq Age Sex Outcome Treatment
    1 NI