BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1888060 · Received October 26, 2010

    Report

    Report Number
    2027969-2010-01805
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 18, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO INRATIO METERS WERE REPORTED INRATIO METER: PART# 100137,(B)(4), 510(K) 0219253. INRATIO2 METER: PART# 200457, (B)(4), 510(K) 072727. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010 (NOT SURE OF ACTUAL DATE), INRATIO: 1.2, LAB: 3.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100139 234591

    Patients

    Seq Age Sex Outcome Treatment
    1