BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2000467 · Received January 31, 2011

    Report

    Report Number
    2027969-2011-00216
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 FILED. INRATIO: 1.1, REFERENCE: 2.5, MEAN: 1.80, CONFIDENCE LIMITS: 1.2-2.3. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. BOTH INRATIO AND REFERENCE VALUES FALL OUTSIDE THE CONFIDENCE LIMITS. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. ADDITIONAL IN-HOUSE INVESTIGATION COULD NOT BE PERFORMED BECAUSE NO STRIP LOT INFO WAS PROVIDED BY THE CUSTOMER. ROOT CAUSE OF COMPLAINT COULD NOT BE DETERMINED. 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 (SALES REP FOR DISTRIBUTOR) ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.1, INRATIO: 2.5. PT'S THERAPEUTIC RANGE: 2.5-3.5 INR. PT ALSO REPORTED A LOW READING OF 0.9 INR ON REPLACEMENT METER.

    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