Model Number 102096-67A |
Device Problem
Failure to Sense (1559)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 11/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
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Event Description
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On (b)(6) 2019, the sensor experienced an early sensor retirement thereby requiring early removal of the inserted device.
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Manufacturer Narrative
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In-vitro qc test shows sensor sn 114212 had experienced loss of chemical performance and "reference on" channel remained at unacceptably low values throughout duration of testing window.The potential cause is because of lack of glucose response from the hydrogel due to hydrogel translucency/insufficient hydration.
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Search Alerts/Recalls
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