BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 240114 · Received September 10, 1999

    Report

    Report Number
    2939301-1999-00743
    Event Type
    Malfunction
    Date Received
    September 10, 1999
    Report Date
    August 13, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT SHE DID A METER TO LAB TEST COMPARISON DURING A ROUTINE LAB VISIT. USING HER OWN METER, THE CAPILLARY TEST AND LAB DRAW WERE DONE APPROXIMATELY 10 MINUTES APART, ABOUT 2.5 HOURS AFTER SHE HAD EATEN HER BREAKFAST. HER READING WAS 114 MG/DL, AND THE VENOUS DRAW LAB TEST RESULT WAS 159 MG/DL. IN HER INITIAL REPORT, SHE STATED SYMPTOMS OF FEELING LIGHTHEADED, BUT THIS WAS NOT CONFIRMED WITH THE LIFESCAN REP ON FOLLOWUP. AFTER RECEIVING CONTROL SOLUTION, THREE FOLLOWUP CONTROL TEST RESULTS WERE IN RANGE, 132, 135 AND 140 (96-144).

    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 76 YR Other