BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    010-411-01F UNK

    MDR report key: 203988 · Received December 22, 1998

    Report

    Report Number
    2939301-1998-01088
    Event Type
    Malfunction
    Date Received
    December 22, 1998
    Report Date
    September 20, 1998
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT SHE HAD GOTTEN THE ER1 MESSAGE, ALONG WITH READINGS OF 480 AND 463 MG/DL THAT DAY, 9/20/98, DURING AN ILLNESS. SHE STATED THAT SHE WAS TAKING MEDICATION FOR SINUS, YEAST, AND BLADDER INFECTIONS, AND WAS NOT FEELING BETTER. SHE PLANNED ON SEEING HER PHYSICIAN THE NEXT DAY. SHE STATED THAT SHE HAD TAKEN HER USUAL AMOUNT OF INSULIN THAT MORNING. DURING A F/U CALL ON 9/27, THE REPORTER'S MOTHER STATED THAT HER DAUGHTER HAD CALLED 911 ON THE DATE OF THE ORIGINAL REPORT, AND HAD BEEN TOLD BY THE EMT TO TAKE ADD'L INSULIN AND MONITOR HOURLY. BY 10:15 PM ON THAT DAY, HER BLOOD SUGAR READING WAS 196 MG/DL. SHE SAID THAT HER DAUGHTER'S BLOOD SUGAR WAS STILL HIGH, BUT UNDER CONTROL. BRIEFLY SPEAKING WITH THE REPORTER, SHE STATED THAT SHE WAS NOT RECOVERING FROM THE BLADDER AND YEAST INFECTION, AND THAT SHE HAD REC'D HER REPLACEMENT METER, BUT WAS TOO ILL TO DO A CHECK ON THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 010-411-01F UNK * CGA LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other