Recall Z-2898-2016 ยท PHV Continuous Glucose Monitor Retrospective Data Analysis Software
Medtronic Inc.
CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically
| Date | Aug 5, 2016 |
| Status | Terminated |
| Reason | Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error. |
| Root cause | Software design |
| Action | Medtronic sent an Urgent Field Corrective Action letter dated August 5, 2016, to affected customers who received the CareLink iPro Therapy Management Software. The letter informed the customers that the recall affects the users of CareLink iPro software who have downloaded reports that include data that was uploaded from certain models of Roche BG meters. Customers were informed that the recall is due to time stamp error and data from certain Roche meters uploaded to CareLink iPro may resulted in incorrect reports. Customers were informed that if they manually enter Logbook data from the Ro |
| Quantity | 33 units |
| Distribution | Nationwide Distribution to TN, MN, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.