BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2935139 · Received January 14, 2013

    Report

    Report Number
    2027969-2013-00040
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" INITIAL RESULT 4.5; REPEAT RESULT 2.2. THE CALLER INDICATED THAT THESE TWO RESULTS WERE TAKEN WITHIN 10 MINUTES OF EACH OTHER ON DIFFERENT HANDS. THEY ALSO STATED THAT THE PHYSICIAN WITHHELD THEIR COUMADIN DOSE FOR 3 DAYS BASED ON THE INRATIO2 RESULT OF 4.5. THERE IS NO INDICATION OF A LAB VALUE THAT CORRESPONDS WITH EITHER OF THE RESULTS ON (B)(6) 2012. THE CALLER PROVIDED A LIST OF RESULTS OBSERVED SINCE BEGINNING TESTING IN (B)(6) 2012. NO INFO WAS PROVIDED CONCERNING TIME FRAMES BETWEEN COLLECTION DATES AND TIMES. THE VALUES PROVIDED WERE AS FOLLOWS: LAB DRAWS: 1.8, 2.2, 3.7, QC LO, 4.5, 2.2 (WITH THE LAST 2 RESULTS WITHIN 10 MINUTES OF EACH OTHER ON DIFFERENT HANDS AS NOTED ABOVE). THERE IS NO INDICATION THAT LAB VALUES ARE DIRECT COMPARISON TO METER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21321 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 287443

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAYS BASED ON THE INR2 OF 4.5.| COUMADIN 2.5 MG/DAY. PHYSICIAN WITHHELD DOSE FOR