BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2064192 · Received April 5, 2011

    Report

    Report Number
    2027969-2011-00708
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 5, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS ON THREE PTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011; PATIENT: #1; LAB: 2.84; INRATIO: 1.2. DATE: (B)(6) 2011; PATIENT: #2; LAB: 1.89; INRATIO: 1.3. DATE: (B)(6) 2011; PATIENT: #3; LAB: 2.74; INRATIO: 1.4. CALLER STATED THAT THEY ARE MILKING THE FINGER FOR ALL THREE PTS TO GET THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 NOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 NI