Model Number 102208-500 |
Device Problem
Imprecision (1307)
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Patient Problem
Hyperglycemia (1905)
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Event Date 02/10/2022 |
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 stopped taking insulin due to low glucose results on transmitter 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)(6) 2022, senseonics was made aware of an incident where the user stopped taking insulin due to low glucose results on transmitter and had to go to the emergency room.
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Manufacturer Narrative
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The investigation confirmed the reported mismatch leading to a pm event, but revealed that the observed slight inaccuracy with the system was due to the wrong use of the calibrations by the customer.The customer was largely using sg values instead of bg values for calibration, which affected the ability of the system to adjust based on the calibrations.As instructed by the l3 team after the event, the customer started calibrating properly and a cc team notes in the 00075753 case read that the customer saw the accuracy greatly improving afterwards.User went to emergency room (er) where he was advised to get back to insulin dosage, on fast and long acting when required.Per case notes of associated sensor inaccuracies complaint (complaintrec-(b)(4) the accuracy of the system has significantly improved after he was educated on calibration best practices.No further resolution was necessary.H6.Investigation findings updated to 213 h6.Investigation conclusion updated to 19.
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Search Alerts/Recalls
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