BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 208349 · Received January 29, 1999

    Report

    Report Number
    2939301-1999-00038
    Event Type
    Malfunction
    Date Received
    January 29, 1999
    Report Date
    January 6, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE RPTR HAD DONE BACK TO BACK TESTING WITH READING OF 131, 141 AND 162 MG/DL, A DIFFERENCE OF 21%. AFTER LIFESCAN HEALTH CARE PROFESSIONAL GAVE INSTRUCTIONS ON CLEANING THE METER, WHICH HAD NEVER BEEN DONE, TEST RESULTS OF 111 AND 102 MG/DL, AN 8% DIFFERENCE, WERE ACHIEVED.

    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 76 YR Other