BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2082684 · Received April 28, 2011

    Report

    Report Number
    2027969-2011-00956
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILLED: INRATIO: 1.3; REFERENCE: 5.9; MEAN: 3.60; CONFIDENCE LIMITS: 2.0-5.0. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. FURTHER INVESTIGATION COULD NOT BE PERFORMED SINCE NO STRIP LOT INFORMATION WAS PROVIDED BY THE CUSTOMER. COMPLAINT ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(4) 2011; INRATIO: 1.3; LAB: 5.9. PATIENT'S THERAPEUTIC RANGE: 2.0-3.0 INR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI