BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2190284 · Received July 19, 2011

    Report

    Report Number
    2027969-2011-01574
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    May 27, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. PT (PST) ALSO DID A CORRELATION AGAINST NURSE'S METER AT THE HOSPITAL AND THE LAB ON (B)(6) 2011. RESULTS AS FOLLOWS: PST'S STRIPS; INRATIO2: 4.1, NURSE'S METER: 3.9, LAB: 3.4; NURSE'S STRIPS; INRATIO2: 3.9, NURSE'S METER: 3.4, LAB: 3.4. ON (B)(6) 2011, PT HAD A NOSEBLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 248203

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other