BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2101514 · Received May 19, 2011

    Report

    Report Number
    2027969-2011-01115
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    March 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB FOR INRATIO2 METER. RESULTS AS FOLLOWS: ON (B)(6) 2011, THE PT WAS TRAINED ON THE INRATIO2 METER AND GOT A RESULT OF 1.4. THE PHYSICIAN WAS NOT SURPRISED BY THE LOW RESULT BECAUSE THE PT HAD FINISHED A COURSE OF ANTIBIOTICS AND PREDNISONE FOR BRONCHITIS ON (B)(6) 2011; THE PHYSICIAN INCREASED PT'S COUMADIN DOSE. ON (B)(6) 2011, THE PT GOT AN INRATIO2 RESULT OF 1.4 AND THE PHYSICIAN INCREASED THE COUMADIN AGAIN. ON (B)(6) 2011, THE PT GOT AN INRATIO2 RESULT OF 1.3. A LAB DRAW WAS OBTAINED WITHIN ABOUT TWO HOURS OF THE INRATIO2 TEST AND THE LAB RESULT WAS 4.2. PT'S THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 246050

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other