Events

Recall of Medtronic CareLink iPro Therapy Management Software, MMT7340

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78298
  • Event Risk Class
    Class 2
  • Event Number
    Z-0670-2018
  • Event Initiated Date
    2017-10-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159083
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Artificial pancreas device system, threshold suspend - Product Code OZO
  • Reason
    Due to a time conversion error, data uploaded from the ipro(tm)2 recorder to the carelink ipro software using the new carelink ipro uploader feature may result in incorrect reports. this pertains only to reports generated between september 23, 2017 and september 27, 2017 that used the new carelink ipro uploader feature.
  • Action
    A communication is being sent to all healthcare professionals who had uploaded reports using the universal uploader feature between September 23, 2017 to September 27, 2017. The method is by mail and by email, with a response requested from the healthcare professional to confirm they have received and read the notice. For further questions please call (877) 874-7717

Device

Medtronic CareLink iPro Therapy Management Software, MMT7340
  • Model / Serial
    Version 1.12
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution
  • Product Description
    Medtronic CareLink iPro Therapy Management Software, MMT-7340 || The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iPro software is used to upload glucose sensor data stored on a recording device, capture BG meter readings through manual entry or wired-upload, retrospectively calibrate sensor data, and provide retrospective reports of continuous glucose information. The reports generated by the CareLink iPro software are intended for use by healthcare professionals to assist with diabetes clinical assessment, patient education, and therapy optimization.
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Manufacturer Address
    Medtronic Inc., 18000 Devonshire St, Northridge CA 91325-1219
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA