Recall Z-1501-2016— Medtronic MiniMed Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic MiniMed Inc., initiated 2016-02-19, terminated 2016-05-16. FDA's recall record names no specific 510(k) clearance for this event. Product: CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information. 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..
- Recalling firm
- Medtronic MiniMed Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-19
- Terminated
- 2016-05-16
- Firm location
- Northridge, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.