BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 214644 · Received March 11, 1999

    Report

    Report Number
    2939301-1999-00123
    Event Type
    Malfunction
    Date Received
    March 11, 1999
    Report Date
    February 12, 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

    REPORTER TESTED BACK-TO-BACK FOR COMPARISON AND REC'D A BLOOD GLUCOSE RESULT OF 142 AND 281 MG/DL. REPORTER STATED SHE MAY HAVE HAD TOO MUCH BLOOD ON THE TESTSTRIP. OTHER READINGS WERE 122 MG/DL IN THE MORNING AND 178 MG/DL IN THE EVENING. REPORTER WAS NOT FEELING WELL, STATING SHE WAS VERY TIRED. CONTROL SOLUTION READING WAS 128 (102-154) MG/DL.

    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