BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 329350 · Received April 23, 2001

    Report

    Report Number
    2939301-2001-00363
    Event Type
    Malfunction
    Date Received
    April 23, 2001
    Report Date
    March 22, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THEIR BACK TO BACK TEST READINGS ON THEIR SS METER WERE 211, 212 AND 91 MG/DL (71% DIFFERENCE). CONTROL SOLUTION READING WAS IN RANGE. NO SYMPTOMS WERE REPORTED. TESTS WERE DONE USING THE SAME FINGER STICK. LFS REPRESENTATIVE REVIEWED QC PROCEDURES AND DISCUSSED BACK TO BACK TESTING PROCEDURES VERSUS METER/LAB COMPARISONS. THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18605 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CGA LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other