BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2852893 · Received November 27, 2012

    Report

    Report Number
    2027969-2012-01638
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS WHILE PERFORMING A VALIDATION. RESULTS AS FOLLOWS: PATIENT 1: INRATIO2: 6.9, TRADITIONAL METHOD: 2.3. PATIENT 2: 4.3, 2.1. NO PATIENT INFORMATION WAS PROVIDED. CUSTOMER HAS THREE METERS AND DID NOT KNOW WHICH METER WAS USED TO OBTAIN THE RESULTS. REFERENCE MDS NUMBERS 2027969-2012-01636 AND 2027969-2012-01637.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 281267

    Patients

    Seq Age Sex Outcome Treatment
    1