BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUET GLUCOSE MONITORING SYSTEM

    MDR report key: 178916 · Received July 23, 1998

    Report

    Report Number
    2031335-1998-00001
    Event Type
    Injury
    Date Received
    July 23, 1998
    Date of Event
    June 10, 1998
    Report Date
    July 22, 1998
    Manufacturer
    LXN CORP.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT, A TYPE I DIABETIC, WHILE ON HIS HONEYMOON IN EUROPE, WENT INTO DIABETIC COMA ON TWO DIFFERENT DAYS. PT STATED THAT HE MEDICATES BASED ON GLUCOSE READINGS AT BREAKFAST, DINNER AND BEDTIME. BOTH COMAS WERE A RESULT OF MEDICATION BASED ON BEDTIME GLUCOSE READINGS. PT WAS UNSURE OF SPECIFIC DATES OF THE COMAS. PT STATED HE WAS REVIVED BY HOTEL STAFF/DOCTOR AND WAS GIVEN ORANGE JUICE. PT ALLEGED HE WAS UNSURE OF THE GLUCOSE VALUES OBTAINED. THE VALUES DID NOT MATCH HOW PT WAS FEELING. PT STATED THAT HE DID NOT CONTACT HIS HEALTHCARE PROFESSIONAL REGARDING THE INCIDENTS IMMEDIATELY FOLLOWING HIS RETURN TO THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUET GLUCOSE MONITORING SYSTEM GLUCOSE METER/GLUCOSE TEST STRIPS CGA LXN CORP. NA 0300050

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention INSULIN, AIR JET INJECTOR (SYRINGE).