BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 309929 · Received December 18, 2000

    Report

    Report Number
    2939301-2000-01143
    Event Type
    Malfunction
    Date Received
    December 18, 2000
    Report Date
    November 22, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT BACK TO BACK TESTS PERFORMED ON USER'S SURESTEP METER WERE 161, 101 AND 119 MG/DL (47% DIFFERENCE). NO SYMPTOMS WERE REPORTED. THERE WAS NO ALLEGATION OF HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other