BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK ADVANTAGE

    MDR report key: 33006 · Received May 15, 1996

    Report

    Report Number
    MW1009102
    Event Type
    Injury
    Date Received
    May 15, 1996
    Date of Event
    May 6, 1995
    Report Date
    May 13, 1996
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON THE EVENING OF 5/6/95 DIABETIC PT DEVELOPED A TERRIBLE HEADACHE ON THE WAY TO A SOCIAL FUNCTION. AS THIS CAN BE A SIGN OF HIGH BLOOD SUGAR, PT USED NEW METER. THE FIRST READING AT 9:35 PM WAS 352. THE SECOND READING AT 9:45 PM WAS 571. PT TOOK 6 UNITS OF REGULAR INSULIN, THE APPROPRIATE DOSE AND TYPE FOR THESE UNUSUALLY HIGH READINGS. PT IMMEDIATELY RETURNED HOME AND RECHECKED BLOOD SUGAR AT 9:58 PM WITH OLD METER. THIS THIRD READING WAS 180. PT DRANK A LOT OF JUICE TO COUNTERACT THE INSULIN AND WAS DRIVEN TO THE HOSP TO USE ONE OF THEIR MACHINES. FOURTH READING WAS 140. AFTER PT RETURNED HOME, PT MONITORED SUGAR LEVELS. LAST READINGS AT 12:53 AM WAS 152.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK ADVANTAGE BLOOD GLUCOSE METER CFR BOEHRINGER MANNHEIM CORP. 870 400119

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| L| R