CareLink Software Suite (2020-10-28)

Starting date:

October 28, 2020

Posting date:

November 27, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74407

Last updated:
2020-11-27

• 
  Reason
• 
  Affected products

Affected Products

A. Carelink Personal

B. Carelink Software

Reason

Medtronic released an update to the CareLink software suite on Saturday, August 29, 2020. Following this release, customers who generated a Device Settings report from CareLink Personal or CareLink system software may have been presented with an inaccurate carbohydrate ratio setting on their CareLink report. This only occurred under the following circumstances where:

1. The carbohydrate unit of measurement in CareLink Software is set to grams, but the insulin pump is set to exchanges.
2. The carbohydrate unit of measurement in CareLink Software is set to exchanges, but the insulin pump is set to grams.

If adjustments were made to the carbohydrate ratio based on the CareLink Device Settings report, this could lead to either over or under delivery of insulin. This could cause low blood glucose (hypoglycemia, loss of consciousness, seizure, death), and/or high blood glucose (hyperglycemia).

On September 30, 2020, Medtronic released an automatic update to CareLink software which resolved the issue described above. However, some customers may have adjusted their carbohydrate ratio between August 29, 2020 and September 30, 2020 using incorrect data on the Device Settings report.

Affected products