BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 229444 · Received June 25, 1999

    Report

    Report Number
    2939301-1999-00463
    Event Type
    Malfunction
    Date Received
    June 25, 1999
    Report Date
    May 26, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT HE DID BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN 10 MINUTES, USING SEPARATE FINGERSTICKS. HE STATED THAT HIS RESULTS WERE 200, 150 MG/DL AND "UP." HE STATED THAT HE DID NOT HAVE ANY SYMPTOMS. A CONTROL SOLUTION TEST WAS IN RANGE 118 (85-127). ATTEMPTS TO CONTACT THE REPORTER FOR ADD'L INFO HAVE NOT BEEN SUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other