BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1833076 · Received September 9, 2010

    Report

    Report Number
    2027969-2010-01403
    Event Type
    Other
    Date Received
    September 9, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 9, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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) 2010; INRATIO: 1.5; LAB: 3.5. PATIENT CAME ON (B)(6) 2010 WITH NOSE AND RECTAL BLEEDS. TESTED 1.5 AT OFFICE INRATIO; SENT TO LAB AND GOT 3.5. NEW LOT OF STRIPS, EASY TO OBTAIN SAMPLE, STORED AT RT, NO RECENT CHANGES IN ANY MEDS / NO ANEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234588

    Patients

    Seq Age Sex Outcome Treatment
    1 Other