BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2000488 · Received January 31, 2011

    Report

    Report Number
    2027969-2011-00218
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 10, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IMPRECISION DATA PROVIDED BY END-USER: 1ST INR: 2.9, 2ND INR: 1.3, 3RD INR: 2.6, MEAN: 2.27, SD: 0.85, %CV: 37.52. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF 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. PER GENERAL DESCRIPTION OF COMPLAINT, CUSTOMER HAD DIFFICULTY OBTAINING ENOUGH BLOOD SAMPLE FOR TESTS. CUSTOMER WAS ALSO MILKING THE FINGER AND HAVING TROUBLE GETTING BLOOD ONTO THE RIGHT PART OF THE STRIP. IMPROPER SAMPLING TECHNIQUE COULD HAVE CONTRIBUTED TO THE INACCURATE INR RESULTS. PT ALSO HAS HYPOTHYROIDISM AND WAS TAKING ASPIRIN AND OTHER MEDICATIONS. PER PRODUCT USER GUIDE, CERTAIN OVER-THE-COUNTER DRUGS AND PRESCRIPTION MEDICATIONS COULD AFFECT COAGULATION TESTING AND LEAD TO INACCURATE INR RESULTS. ROOT CAUSE OF COMPLAINT COULD NOT BE DETERMINED FROM THE INFO 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 (PT'S DAUGHTER) ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INR: 2.9, 1.3; 2.6.

    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