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
Affected Products
- Carelink Personal
- Carelink Software
- 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:
- 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.
- 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
A. Carelink Personal
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MMT-7333WW
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
B. Carelink Software
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MMT-7350
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES
C. Carelink Uploader
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ACC-7350
Companies
- Manufacturer
-
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES