Recall Z-1501-2016 ยท OUG Medical Device Data System
Medtronic MiniMed Inc.
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
| Date | Feb 19, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | An Urgent Field Safety Notice was sent to customers on 2/19/16 to make customers aware of an iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 21 CareLink iPro reports. The letter informs customers that the affected 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 letter informs the customers of the requested next steps and to contact Maneesh Shrivastav, Director of Strate |
| Quantity | 20 |
| Distribution | US: MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.