BEUDAMED
    FDA Enforcement Class II Terminated

    CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information

    Recall: Z-1501-2016 · Reported April 27, 2016

    Enforcement

    Recall Number
    Z-1501-2016
    Event ID
    73451
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic MiniMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2016
    Initiation Date
    February 19, 2016
    Classification Date
    April 15, 2016
    Termination Date
    May 16, 2016
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    Description

    CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information

    Reason

    Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.

    Code Info

    n/a

    Distribution

    US: MN

    Quantity

    20