Model Number 102096-67A |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Hypoglycemia (1912)
|
Event Date 08/02/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
|
|
Event Description
|
On (b)(6) 2019, senseonics was made aware of an adverse event where the user experienced a hypoglycemia event.The user did not require medical attention.
|
|
Manufacturer Narrative
|
This mdr is result of a retrospective review of complaints.Per case notes, transmitter was removed before the time of the event due to alarm fatigue and user requested not to be contacted by the hcp.The system was not operating during the hypo event.No further investigation is needed.H6 method code updated to 4114.H6 result code updated to 3221.H6 conclusion code updated to 67.
|
|
Search Alerts/Recalls
|