Class 2 Device Recall CareLink iPro2 Reports (MMT7340)

• Date Initiated by Firm: February 19, 2016
• Create Date: October 11, 2018
• Recall Status: Terminated on May 16, 2016
• Recall Number: Z-1501-2016
• Recall Event ID: 73451
• Product Classification: Medical device data system - Product Code OUG
• Product: CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
• Code Information: n/a
• FEI Number: 3003166194
• Recalling Firm/ Manufacturer: Medtronic MiniMed Inc.; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: 818-576-4700
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Employee error
• Action: An Urgent Field Safety Notice was sent to customers on 2/19/16 to make customers aware of an iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 21 CareLink iPro reports. The letter informs customers that the affected 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 letter informs the customers of the requested next steps and to contact Maneesh Shrivastav, Director of Strategy at Medtronics Diabetes by email at maneesh.shrivastav@medtronic.com or call (763) 526-3509 if they have any questions.
• Quantity in Commerce: 20
• Distribution: US: MN
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.