Model Number 102812-67A |
Device Problem
Imprecision (1307)
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Patient Problem
Hypoglycemia (1912)
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Event Date 12/28/2021 |
Event Type
Injury
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Event Description
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On (b)(6) 2022, senseonics was made aware of an incident where the user experienced low glucose symptoms and had to go to the emergency room.
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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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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)(4) 2022, senseonics was made aware of an incident where the user experienced low glucose symptoms and had to go to the emergency room.
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Manufacturer Narrative
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User could not provide any further details like glucose values, date and time of the incident.User was reached out multiple times to follow up regarding this incident and to get further details.However, no response was received from the user.Per data management system (dms), there is no use of system since (b)(6) 2022.Per case notes, user was admitted to er where user was given glucose water and some resting was enough.No further resolution was possible for this complaint due to lack of response from the user.H6.Investigation finding updated to 3221.H6.Investigation conclusions updated to 67.
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Search Alerts/Recalls
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