BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 247783 · Received October 29, 1999

    Report

    Report Number
    2939301-1999-00945
    Event Type
    Malfunction
    Date Received
    October 29, 1999
    Report Date
    November 4, 1998
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT SHE GOT A "HI" AND THEN AN ER1 MESSAGE. TWO BG TESTS WERE DONE WHILE ON THE PHONE WITH RESULTS OF 110 AND 113 MG/DL. REPORTER GAVE METER MEMORY AS OF 11/4/1998: 113, 110 ER1, ER5, HI, HI, 150, 217, 212 AND 106. NO INFO WAS PROVIDED ON WHETHER OR NOT SHE COMPARED THE CONFIRMATION DOT TO THE COLOR CHART WHEN SHE HAD TESTED. NO HARM WAS ALLLEGED.

    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 78 YR Other