BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 323048 · Received March 23, 2001

    Report

    Report Number
    2939301-2001-00262
    Event Type
    Malfunction
    Date Received
    March 23, 2001
    Report Date
    February 23, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT BACK TO BACK TEST READINGS THE PT OBTAINED (ON THE SS METER) USING SEPARATE FINGER STICKS WERE 93, 100, 143, 293, 300 AND 305 MG/DL. NO SYMPTOMS WERE REPORTED. PT WAS TO RETEST WITH NEW SUPPLIES (CONTROL SOLUTION REPORTEDLY EXPIRED/OPEN LONGER THAN 3 MONTHS). LFS REP REVIEWED QC PROCEDURES AND METER/LAB COMPARISONS. THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13163 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other