BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURESTEP

    MDR report key: 388601 · Received March 5, 2002

    Report

    Report Number
    2939301-2002-03118
    Event Type
    Death
    Date Received
    March 5, 2002
    Report Date
    January 23, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CALLED IN 2002, ALLEGING THAT THEIR SURESTEP METER GAVE INACCURATE LOW READINGS. CUSTOMER CALLED IN ABOUT THE CLASS ACTION LAW SUIT TO HAVE SELF INCLUDED IN THE CASE. CUSTOMER STATED THAT CUSTOMER KNEW THEY WAS NOT GETTING RIGHT READINGS ON THAT METER AND THAT IS WHY SPOUSE IS NOW DECEASED. CUSTOMER NO LONGER HAS THE METER OR SERIAL NUMBER AND CANNOT RECALL ANY SPECIFIC READINGS THEY FELT WERE INACCURATE. ATTEMPTS TO CONTACT CUSTOMER TO OBTAIN MORE INFO HAVE FAILED. CO IS SENDING A LETTER. IF CO OBTAIN ANY ADDITIONAL INFO A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death