BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 214636 · Received March 11, 1999

    Report

    Report Number
    2939301-1999-00135
    Event Type
    Malfunction
    Date Received
    March 11, 1999
    Report Date
    February 12, 1999
    Manufacturer
    LIFESCAN INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER'S METER RESULT WAS 356 MG/DL WHEN COMPARED TO LAB RESULT OF 291 MG/DL. THE LAB COMPARISON WAS DONE BACK TO BACK, CAPILLARY, VEINOUS RESPECTIVELY. REPORTER STATED THAT SHE HAD EATEN ONE HOUR BEFORE THE TEST AND WAS NOT EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE AT THE TIME. A CONTROL SOLUTION TEST WAS IN RANGE 131(101-152).

    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