Medtronic MiniMed Inc. recalls CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides…

Recall date

February 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1501-2016

FDA classification

Class II

Brand / firm

Medtronic MiniMed Inc.

Sold / distributed

US: MN

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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