BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESSVIEW BLOOD GLUCOSE MONITOR SYSTEM

    MDR report key: 410228 · Received August 1, 2002

    Report

    Report Number
    2031335-2002-00006
    Event Type
    Injury
    Date Received
    August 1, 2002
    Date of Event
    July 2, 2002
    Report Date
    August 1, 2002
    Manufacturer
    LXN CORP.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A DIABETIC PT RECEIVED A TEST RESULT OF 22 MG/DL FROM THEIR EXPRESSVIEW MONITOR AND THEY WENT TO THE ER. WHILE AT THE HOSP ER, APPROX 30 MINS AFTER RECEIVING THE TEST RESULT OF 22 MG/DL, THE PT'S GLUCOSE LEVEL WAS RE-ASSESSED. THEIR GLUCOSE LEVEL WAS 154 MG/DL. THE PT WAS NOT GIVEN ANY FURTHER TREATMENT AND THEY WERE RELEASED FROM THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESSVIEW BLOOD GLUCOSE MONITOR SYSTEM GLUCOSE MONITOR/TEST STRIPS CGA LXN CORP. NA 20025 0700464

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization