BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 201917 · Received December 9, 1998

    Report

    Report Number
    2939301-1998-01026
    Event Type
    Malfunction
    Date Received
    December 9, 1998
    Report Date
    September 25, 1998
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT SHE HAD GOTTEN THE ERL MESSAGE, AS WELL AS A HI MESSAGE. DURING HER HOME NURSE'S VISITS SHE WOULD TEST USING THE NURSE'S METER, AND GET A HIGH RESULT, IN THE 400-500 MG/DL RANGE. HER NURSE WOULD CALL HER PHYSICIAN FOR DIRECTIONS ON MEDICATION, SINCE THE REPORTER IS ON A SLIDING SCALE. THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESTEP BLOOD GLUCOSE METER CGA LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other