BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2072989 · Received April 22, 2011

    Report

    Report Number
    2027969-2011-00905
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011; INRATIO: 1.8, 1.4; LAB: 2.8, 2.6. CALLER STATED THAT SHE HAS HAD ISSUES FOR THE LAST THREE MONTHS. TECHNICAL SERVICE REP HAD CALLER RETEST WHILE ON THE PHONE USING THE NEW LOT AND HER RESULT WAS WITHIN THE EXPECTED RANGE (2.0-3.0) AT 2.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1