BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1432047 · Received April 15, 2009

    Report

    Report Number
    2027969-2009-00221
    Event Type
    Malfunction
    Date Received
    April 15, 2009
    Date of Event
    March 17, 2009
    Report Date
    April 15, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAR-20-2009. UNABLE TO PERFORM RETAINED STRIP TEST DUE TO UNK STRIP LOT # ON THE EVENT DETAILS. NO FURTHER INVESTIGATION IS REQUIRED. NO CORRECTIVE ACTION IS REQUIRED AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. AS OF MARCH 20, 2009, THE METER/NOR THE STRIPS ARE EXPECTED TO RETURN. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST COMPARED TO LAB. RESULTS AS FOLLOWS: DATE: 2009, INRATIO: 1ST INR=1.8; 2ND INR=1.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0100139 NG

    Patients

    Seq Age Sex Outcome Treatment
    1 NI