Official recall record

CareLink™ Software

What the authority reported

Medtronic recently identified two issues causing the data that was displayed on the 24-hour sensor glucose overview graph within CareLink™ clinic to be incorrect. Both issues were limited to the 24-hour sensor glucose overview graph on the patient dashboard and occurred when switching between the 14-day view and the 30-day view. The first issue occurred when the user changed the graph from the 14-day view to the 30-day view, and the graph would sometimes display hypoglycemic patterns from both the 14-day and 30-day date ranges when only the 30-day pattern should have been visible. The second issue occurred when a user navigated back to the patient dashboard tab from another tab within CareLink™ clinic and selected to view the 30-day date range on the sensor glucose overview graph, the graph would indicate that it is in the 30-day view, but would incorrectly display data from the 14-day date range rather than the 30-day date range.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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