BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 704218 · Received November 14, 2005

    Report

    Report Number
    2939301-2005-04939
    Event Type
    Malfunction
    Date Received
    November 14, 2005
    Report Date
    November 1, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    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

    THE PT REPORTED BLOOD GLUCOSE RESULTS OF "177 MG/DL" WITH THE LIFESCAN METER AND "141 MG/DL" ON A LAB DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. THE PT ALSO REPORTED SEVERAL OTHER BLOOD GLUCOSE RESULTS OF "100 MG/DL" WITH THE LIFESCAN METER AND "86 MG/DL" ON A LAB DEVICE; "78 MG/DL" WITH THE LIFESCAN METER AND "69 MG/DL" ON A LAB DEVICE; "166 MG/DL" WITH THE LIFESCAN METER AND "143 MG/DL" ON A LAB DEVICE; "120 MG/DL" WITH THE LIFESCAN METER AND "95 MG/DL" ON A LAB DEVICE; "71 MG/DL" WITH THE LIFESCAN METER AND "71 MG/DL" ON A LAB DEVICE; "103 MG/DL" WITH THE LIFESCAN METER AND "88 MG/DL" ON A LAB DEVICE; "96 MG/DL" WITH THE LIFESCAN METER AND "76 MG/DL" ON A LAB DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESTEP GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 285110A008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN