Carelink (2020-12-11)

Starting date:

December 11, 2020

Posting date:

December 31, 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-74683

Last updated:
2020-12-31

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  Reason
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  Affected products

Affected Products 

1. Carelink Personal
2. Carelink Software
3. Carelink Uploader

Reason

Notification regarding potential issue related to missing or incomplete basal rate settings on Carelink reports. Medtronic released an update to the Carelink Uploader on Saturday, October 3, 2020. The installation of the new uploader, version 3.1.5.000, to a computer that was subsequently used to generate a Carelink report may result in one of the following scenarios:

1. Some reports may be missing all programmed basal rates in the device. This may result in a blank value on the device settings report of the 24-hour basal total.
2. Some reports may only display certain programmed basal rates and some basal rates in the device may be missing from the reports. This may result in a miscalculation on the device settings report of the 24-hour basal total.

The following reports from Carelink software may be affected by this issue: device settings, daily review/daily details, weekly review, and sensor & meter overview.

Historically, Carelink reports have been utilized to adjust therapy settings or to transfer settings from an old pump to a new pump. If all of the following are true, it could lead to either over- or under-delivery of insulin which may result in low blood glucose (hypoglycemia, loss of consciousness), and/or high blood glucose (hyperglycemia).

On November 12, 2020, a new version of the Carelink Uploader was released. This Uploader completely resolves this issue but must be installed on each computer that is used to upload devices to the Carelink software system. Until the new Carelink Uploader version 3.1.6.000 has been installed, the basal rates may be missing or incomplete on Carelink reports.

Affected products