PlainRecalls
FDA Devices Moderate 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

Reported: April 27, 2016 Initiated: February 19, 2016 #Z-1501-2016

Product Description

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

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.

Details

Recalling Firm
Medtronic MiniMed Inc.
Units Affected
20
Distribution
US: MN
Location
Northridge, CA

Frequently Asked Questions

What product was recalled?
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information. Recalled by Medtronic MiniMed Inc.. Units affected: 20.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 27, 2016. Severity: Moderate. Recall number: Z-1501-2016.