BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 2142986 · Received June 21, 2011

    Report

    Report Number
    2027969-2011-01377
    Event Type
    Other
    Date Received
    June 21, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011; INRATIO: 5.7, 6.3, 6.4; LAB: 4.2; DATE: (B)(6) 2011; INRATIO: 4.4, 3.2. CUSTOMER OBSERVED DISCREPANT RESULTS ON THREE DIFFERENT STRIP LOTS: (B)(6) 2011: 11:30 AM INRATIO=5.7 (608DA), 6.3 (45728), 6.4 (243104), 1:00 PM LAB=4.2. THE FIRST TWO STRIPS WERE FROM THE TRAINER'S SUPPLIES; PATIENT USED HER OWN STRIP FOR THE LAST RESULT. THERAPEUTIC RANGE: 2-3. LAST DOSE OF COUMADIN TAKEN ON (B)(6) 2011, DOCTOR HELD DOSAGE TUESDAY NIGHT DUE TO INRATIO READINGS. PATIENT WANTS TO KEEP HER RESULTS HIGH BECAUSE SHE HAS HAD TWO PULMONARY EMBOLISMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other