FDAFebruary 19, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

medtronic minimedmedtronic

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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