BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 209033 · Received February 4, 1999

    Report

    Report Number
    2939301-1999-00043
    Event Type
    Malfunction
    Date Received
    February 4, 1999
    Report Date
    January 5, 1999
    Manufacturer
    LIFESCAN INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE REPORT'S MOTHER HAD GOTTEN AN ERL MESSAGE ON A METER PURCHASED THAT DAY, JAN 5. HER MOTHER WAS THROWING UP AND HAD BEEN ILL. A CONTROL TEST PERFORMED DURING THE CALL WAS IN-RANGE. ALL READINGS TAKE SUBSEQUENT TO THE FIRST RESULT YIELD "HI," CONSISTENT WITH THE PT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESTEP BLOOD GLUCOSE METER CFR LIFESCAN INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other