Model Number 102096-67A |
Device Problem
Failure to Sense (1559)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
|
Event Date 11/19/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
|
|
Event Description
|
On (b)(6) 2019, the sensor experienced an early sensor retirement thereby requiring early removal of the inserted device.
|
|
Manufacturer Narrative
|
The sensor was investigated and the issue was confirmed during qc testing in-house.Intermittent led failures were detected during this test.The investigation shows the system correctly disabled the sensor due to performance failure and the system's self-test functions are working normally.
|
|
Search Alerts/Recalls
|