Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1501-2016

February 19, 2016

Class II

Product summary

Firm
Medtronic MiniMed Inc.
Event
Event 73451
Status
Terminated
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-1501-2016

Official wording

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 information: n/a

Distribution pattern: US: MN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.