BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3770338 · Received March 7, 2014

    Report

    Report Number
    2027969-2014-00196
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 17, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE LOT NUMBER OR RETURN PRODUCTS FOR INVESTIGATION. FURTHER INVESTIGATION WAS NOT POSSIBLE WITHOUT ADD'L INFO. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, AND A LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORD REVIEW WAS NOT PERFORMED AND FURTHER INVESTIGATION WAS NOT POSSIBLE. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: INRATIO: 1.5, LAB: 2.0. TIME BETWEEN TESTS: 1 HOUR. THERAPEUTIC RANGE: 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139620 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN