BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3853413 · Received April 4, 2014

    Report

    Report Number
    2027969-2014-00293
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE VALID LOT NUMBERS OR RETURN PRODUCTS FOR INVESTIGATION. UNABLE TO PERFORM FURTHER INVESTIGATION WITHOUT ADDITIONAL INFORMATION. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. MANUFACTURING RECORD REVIEW WAS NOT PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED. FURTHER INVESTIGATION WAS NOT POSSIBLE. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGING RECEIVING DISCREPANT HIGH INRATIO VALUE. (B)(6) 2014. INRATIO 2.1. LAB 1.6. TIME BETWEEN TESTING ON HOUR. PATIENT'S THERAPEUTIC RANGE 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205124 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 INFECTION| SYPRIL -DOSE, UNKNOWN| ANTIBIOTIC-TYPE AND DOSE, UNKNOWN-RESPIRATORY| ORAL ANTICOAGULANTS, COUMADIN