BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 214657 · Received March 11, 1999

    Report

    Report Number
    2939301-1999-00130
    Event Type
    Malfunction
    Date Received
    March 11, 1999
    Report Date
    February 11, 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

    REPORTER'S METER-TO-LAB (VENOUS DRAW), BACK-TO-BACK FASTING COMPARISON, WAS 134 AND 250 MG/DL RESPECTIVELY. CONTROL SOLUTION TEST WAS 152, 149(96-144) MG/DL. REPORTER WAS USING EXPIRED CONTROL SOLUTION. REPORTER WAS NOT EXPERIENCING ANY SYMPTOMS.

    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 79 YR Other