BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 237287 · Received August 20, 1999

    Report

    Report Number
    2939301-1999-00649
    Event Type
    Malfunction
    Date Received
    August 20, 1999
    Report Date
    July 23, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE RPTR STATED THAT SHE DID BACK TO BACK BLOOD GLUCOSE TESTING, IN RAPID SUCCESSION, USING DIFFERENT FINGER STICKS. HER RESULTS WERE 121, 49 AND 105 MG/DL. SHE DID NOT HAVE ANY SYMPTOMS. A CONTROL SOLUTION TEST WAS IN RANGE, 131 (124-136).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other