BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESSVIEW BLOOD GLUCOSE MONITOR SYSTE

    MDR report key: 352048 · Received September 10, 2001

    Report

    Report Number
    2031335-2001-00001
    Event Type
    Injury
    Date Received
    September 10, 2001
    Date of Event
    August 5, 2001
    Report Date
    September 10, 2001
    Manufacturer
    LXN CORPORATION
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT, A TYPE 2 DIABETIC, OBTAINED A GLUCOSE VALUE OF 53 MG/DL AT 7:00 AM ON THE DAY OF THE EVENT. THE PT CALLED 911 AND WAS TAKEN TO THE HOSP. AN IV WAS ADMINISTERED AT THE HOSP AND APPROX 1 HOUR LATER, THE PT'S GLUCOSE LEVEL WAS 176 MG/DL. THE PT WAS RELEASED FROM THE HOSP APPROX 1/2 HOUR LATER. APPROX 1 WEEK AFTER THE EVENT, THE PT PHONED THE MONITOR MFR BECAUSE PT CONTINUED TO OBTAIN GLUCOSE LEVELS THAT WERE LOWER THEN EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41242 EXPRESSVIEW BLOOD GLUCOSE MONITOR SYSTE GLUCOSE MONITOR/TEST STRIPS CFR LXN CORPORATION NA 8027 0600147

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R GLUCOTROL XL, 5 MG, 2X PER DAY.