TANDEM DIABETES CARE T:SLIM X2, BASAL-IQ, MMOL/L; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
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Model Number 1002717 |
Device Problems
Crack (1135); Poor Quality Image (1408)
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Patient Problem
Fall (1848)
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Event Date 03/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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Device not returned.
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Event Description
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It was reported that the customer experienced low blood glucose (value not provided) and customer fell causing the pump touchscreen to crack.The bottom area of touchscreen was distorted.Customer was not injured and required no assistance.Customer drank juice to address low bg.Cause of low bg was not reported.Although multiple attempts were made, no additional information was provided.
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Manufacturer Narrative
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The failure investigation has been completed.Based on the analysis, the alleged touchscreen issue was verified; however, no failure was identified related to the low bg issue.
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Manufacturer Narrative
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Tandem quality engineer evaluated pump data and concluded the following: there is no evidence of device malfunction.
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Search Alerts/Recalls
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