BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3063381 · Received April 11, 2013

    Report

    Report Number
    2027969-2013-00293
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    HOME HEALTH CARE NURSE CALLED IN REPORTING IMPRECISE RESULTS ON ONE PATIENT - AT THE TIME THIS NURSE CALLED IN, SHE DID NOT HAVE ANY INFORMATION ON LOT NUMBER OR SERIAL NUMBER. INITIAL READING 4.9, REPEAT 6.0, SECOND REPEAT 5.4. THREE MINUTES BETWEEN EACH TEST. NO LAB RESULTS. PATIENT'S THERAPEUTIC RANGE 2.5 - 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154938 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139

    Patients

    Seq Age Sex Outcome Treatment
    1 ORAL ANTICOAGULANTS - E.G., COUMADIN, WARFARIN