BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 319061 · Received February 27, 2001

    Report

    Report Number
    2939301-2001-00180
    Event Type
    Malfunction
    Date Received
    February 27, 2001
    Report Date
    January 29, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED SS METER RSULTS (190, 186) WERE INCONSISTENT WITH THE PT'S SYMPTOMS OF HYPOGLYCEMIA (SWEATY, DIZZY). THE PATIENT TREATED THEMSELVES WITH ORANGE JUICE BEFORE THE EMTS ARRIVED TO TAKE THE PATIENT TO THE HOSPITAL. PATIENT WAS NOT TREATED FOR LOW BS (BY EMTS OR THE ER) AND STATED "NO" WHEN ASKED (BY THE LFS REP) IF BELIEVED THE METER CAUSED THE PATIENT TO GO TO ER. LFS REP REVIEWED QC PROCEDURES AND DISCUSSED METER/LAB COMPARISONS. THE METER WAS REPLACED. THERE WAS NO ALLEGATIONS OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7977 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other