BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 240271 · Received September 10, 1999

    Report

    Report Number
    2939301-1999-00735
    Event Type
    Malfunction
    Date Received
    September 10, 1999
    Report Date
    August 11, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT HE DID 3 BACK TO BACK BLOOD GLUCOSE TESTS, EACH WITHIN 10 MINUTES. HIS RESULTS WERE 131, 306; 360, 280; AND 220, 178 MG/DL, USING SEPARATE FINGER STICKS. HE DID NOT HAVE ANY SYMPTOMS. A CONTROL SOLUTION TEST WAS NOT DONE DUE TO UNAVAILABILITY OF SUPPLIES. NO FURTHER INFORMATION WAS PROVIDED, AND ATTEMPTS TO FOLLOWUP WITH THE REPORTER HAVE BEEN UNSUCCESSFUL.

    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