BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1851705 · Received September 27, 2010

    Report

    Report Number
    2027969-2010-01499
    Event Type
    Other
    Date Received
    September 27, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 10; INRATIO: >7.5; RETEST INRATIO: >7.5; LAB: 1.5. PT THERAPEUTIC RANGE IS 2.5-3.5. DOCTOR ADMINISTERED VITAMIN K AFTER TWO >7.5 RESULTS THEN SENT PT TO LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 234590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other