Model Number 102096-67A |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Code Available (3191)
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Event Date 12/03/2019 |
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, senseonics was made aware of a situation where a device is to be removed early due to customer satisfaction (sensor check alerts).
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Manufacturer Narrative
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The customer complaint was confirmed after looking at in-vivo data in dms.The in-vitro qc tests is inconclusive since hydrogel was found to be missing over the portion of sensor optics.Result code updated to 3221.Conclusion code updated to 4315.
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Search Alerts/Recalls
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