BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESCAN SURESTEP PRO GLUCOMETER STRIPS

    MDR report key: 1639112 · Received March 19, 2010

    Report

    Report Number
    MW5015249
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 19, 2010
    Manufacturer
    LIFESCAN
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT HAD FASTING GLUCOMETER BLOOD SUGAR CHECK WITH RESULTS 497. LAB HAD ALSO DRAWN A FASTING BLOOD DRAW ON RESIDENT SAME A.M. - AT 1500, LAB REPORTED RESULTS OF 79 TO FACILITY. FYI: DUE TO NO SERIOUS OUTCOME TO RESIDENT FROM THIS EVENT, VOLUNTARILY REPORTING TO FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESCAN SURESTEP PRO GLUCOMETER STRIPS GLUCOMETER STRIPS CGA LIFESCAN 2992027010

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR