BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 283437 · Received June 23, 2000

    Report

    Report Number
    2939301-2000-00530
    Event Type
    Malfunction
    Date Received
    June 23, 2000
    Report Date
    May 24, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RPTR DID BACK TO BACK (RAPID SUCCESSION) BLOOD GLUCOSE TESTS, WITH RESULTS OF 252, 260 AND 87 MG/DL. RPTR DID NOT HAVE ANY SYMPTOMS. A CONTROL TEST WAS IN RANGE, 131 (94-141). THE RPTR HAD BEEN CLEANING THE METER WITH ALCOHOL. NO HARM WAS ALLEGED. FOLLOWUP ATTEMPTS TO CONTACT THE RPTR FOR FURTHER INFO HAVE NOT BEEN SUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other