Model Number MMT-1715K |
Device Problem
Power Problem (3010)
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Patient Problems
Irritation (1941); Rash (2033)
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Event Date 08/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
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Event Description
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The customer reported via phone call that the insulin pump did not receive a low battery alert prior to the replace battery alert.Customer's blood glucose level was unknown.Customer states the battery was not previously used.Customer states this was the second occurrence of replace battery alert without a low battery warning.Customer advised the insulin pump will need to be replaced.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Device passed displacement test, sleep current measurement, active current measurement and self test.Device was monitored and tested with no unexpected battery power loss noted.(b)(4).
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Search Alerts/Recalls
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