BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1976390 · Received January 28, 2011

    Report

    Report Number
    2027969-2011-00209
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBER: 241836. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. PATIENT HAD TO GO TO THE ER DUE TO A NOSE BLEED THAT WOULD NOT STOP ON (B)(6) 2010. PATIENT ALSO REPORTED QC AND NES ERRORS ON THE METER. TWO STRIP LOTS WERE INVOLVED, BUT PATIENT COULD NOT SAY WHICH LOT NUMBER WAS USED FOR THE RESULTS AND ERRORS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243634

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O