BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1825436 · Received August 31, 2010

    Report

    Report Number
    2027969-2010-01314
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. CALLER ALSO ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INR 4.2, 3.6. DOCTOR PUT PATIENT ON LOVENOX FOR 3 DAYS FOLLOWING (B)(6) 2010 METER READING. FOLLOW UP WITH PATIENT - RESULTS FOR STRIP LOT 233421: DATE: (B)(6) 2010; INRATIO: 3.5; LAB: 3.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 233029

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention