BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 234448 · Received July 28, 1999

    Report

    Report Number
    2939301-1999-00568
    Event Type
    Malfunction
    Date Received
    July 28, 1999
    Report Date
    June 28, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE RPTR STATED THAT SHE DID BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN 10 MINUTES, USING DIFFERENT FINGER STICKS. THE RESULTS WERE 231, 187, 212, 200, AND 161 MG/DL. THE RPTR STATED THAT SHE DID NOT HAVE ANY SYMPTOMS; SHE DID STATE THAT SHE WAS DEHYDRATED AND TAKING A DIURETIC FOR SWOLLEN FEET. NO HARM WAS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other