BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 333214 · Received May 11, 2001

    Report

    Report Number
    2939301-2001-00424
    Event Type
    Malfunction
    Date Received
    May 11, 2001
    Report Date
    April 12, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT THE BACK TO BACK TEST READINGS OBTAINED ON THE METER USING DIFFERENT FINGER STICKS WERE 260, 152 AND 142 MG/DL (64% DIFFERENCE). NO SYMPTOMS WERE REPORTED. CONTROL TEST READING (128) WAS IN RANGE (97-145). LFS REP REVIEWED QC PROCEDURES AND DISCUSSED METER/LAB COMPARISONS VERSUS BACK TO BACK TESTING. (LFS REP RECOMMENDED THAT PT DO METER/LAB COMPARISON.) THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22493 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other