BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2850050 · Received November 26, 2012

    Report

    Report Number
    2027969-2012-01632
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH ANOTHER LOT. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 2.8, LOT: 284364. DATE: (B)(6) 2012, INRATIO: 5.0, LOT: 291547. TIME BETWEEN TESTING WAS LESS THAN 30 MINUTES. PATIENT'S THERAPEUTIC RANGE IS 2.5 - 3.5. IT WAS REPORTED THE PATIENT NOTICED BRUISING. THE PATIENT HAD A LAB COMPARISON PERFORMED THE NEXT DAY. RESULTS AS FOLLOWS. DATE: (B)(6) 2012, INRATIO: 5.0, LAB: 4.8, LOT NUMBER NOT PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 284364

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 1.5 WEEKS PRIOR| COUMADIN, B12| DOXYCYCLINE-STOPPED TREATMENT APPROX.