BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2025298 · Received March 7, 2011

    Report

    Report Number
    2027969-2011-00454
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 7, 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
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER. DATE: (B)(6) 2011; INRATIO: 7.0; LAB: - (STRIP LOT # UNK). DATE: (B)(6) 2011; INRATIO: 4.4; LAB: 3.04 (STRIP LOT # UNK). DATE: (B)(6) 2011; INRATIO: 3.0; LAB: 2.30 (LOT # 234130). PT SELF TESTER REPORTS BRUISING/BLEEDING; DOCTOR ADVISED LAB TEST. TESTING ON (B)(6) 2011 AND (B)(6) 2011 WERE OBTAINED USING A DROP FROM THE VENIPUNCTURE SYRINGE ON THE INRATIO2 METER. UNK STRIP LOT NUMBER - PT DID NOT SAVE BOX AND HAS USED ALL OF THEM. PT WAS ALSO CONCERNED ABOUT STRIP SHIPPING - 1ST BOX WAS LEFT ON HER DOORSTEP DURING A SNOWSTORM. WHEN SHE FOUND IT, IT WAS BURIED IN SNOW AND IT WAS ABOUT -20 DEGREE F OUTSIDE. SECOND BOX OF STRIPS WAS NOT LEFT OUTSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other