BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURESTEP

    MDR report key: 377847 · Received January 31, 2002

    Report

    Report Number
    2939301-2002-01213
    Event Type
    Other
    Date Received
    January 31, 2002
    Report Date
    January 2, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER NAME: SURESTEP ENHANCED. STRIP NAME: LIFESCAN. METER CODE: 5. STRIP CODE: 5. STRIP STORAGE: UNKNOWN. SYMPTOMS: NO SYMPTOMS. A PATIENT REPORTED THEY WERE HOSPITALIZED. THEIR METER ALLEGEDLY WAS INACCURATELY LOW. THE RESULT ON THEIR METER WAS 150 MG/DL.. THE RESULT ON THE DOCTORS METER WAS UNKNOWN. THE TIME DIFFERENCE BETWEEN PATIENT'S METER AND HOSPITAL METER WAS UNKNOWN. TREATMENT WAS UNKNOWN. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization