BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3770349 · Received March 7, 2014

    Report

    Report Number
    2027969-2014-00197
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 17, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE LOT NUMBERS OR RETURN PRODUCTS FOR INVESTIGATION. FURTHER INVESTIGATION WAS NOT POSSIBLE WITHOUT ADD'L INFO. ALTHOUGH THE PRODUCT WAS NOT RETURNED, IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT AND CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR THE UNEXPECTED RESULTS. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, AND A LOT NUMBER WAS NOT PROVIDED, MFG RECORD REVIEW WAS NOT PERFORMED AND FURTHER INVESTIGATION WAS NOT POSSIBLE. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2014, INRATIO: 2.0, DOCTOR'S POC: 1.6, LAB: 1.7. TIME BETWEEN FINGER STICK TESTS AND LAB: 1 HOUR THERAPEUTIC RANGE: 2-3. INRATIO AND DOCTOR'S POC TESTS WERE PERFORMED USING THE SAME FINGER. CALLER REPORTS MILKING FINGER AFTER FINGER STICK, USING ONE FINGER STICK FOR MULTIPLE TESTS AND THE SAMPLE NOT BEING APPLIED IMMEDIATELY AFTER FINGER STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140117 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability COUMADIN