BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 224845 · Received May 19, 1999

    Report

    Report Number
    2939301-1999-00385
    Event Type
    Malfunction
    Date Received
    May 19, 1999
    Report Date
    April 1, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT SHE HAD DONE BACK TO BACK BLOOD GLUCOSE TESTS WITH RESULTS OF 143, 133, 127 AND 97 MG/DL. TESTS WERE WITHIN 10 MINUTES, USING DIFFERENT FINGERSTICKS. SHE STATED THAT SHE DID NOT HAVE ANY SYMPTOMS. THE REPORTER DID NOT HAVE CONTROL SOLUTION AVAILABLE FOR TESTING.

    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 66 YR Other