—#148899

Product

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.

FDA product code: PHV — Continuous Glucose Monitor Retrospective Data Analysis Software
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: n/a

Why it was recalled

Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.

Root cause (FDA determination)

Software design

Action the firm took

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 Roche ACCU-CHEK meters or upload data from a blood glucose meter other than the Roche meters are not affected by the recall situation. Customers with any questions regarding the recall letter are instructed to contact the Medtronic 24-Hour HelpLine at 1.800.646.4633. For questions regarding this recall call 818-576-4700.

Recalling firm

Firm: Medtronic Inc.
Address: 18000 Devonshire Street, Northridge, California 91325-1219

Distribution

Distribution pattern: Nationwide Distribution to TN, MN, and WA

Timeline

Recall initiated: 2016-08-05
Terminated: 2016-10-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148899. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.