Catalog Number STK-GL-115 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The patient experienced adverse events on different days with the same device.The following reports are being submitted: (b)(4).
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Event Description
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Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver display screen became frozen.No additional event or patient information is available.No product or data was provided for evaluation.The complaint confirmation of the receiver display screen becoming frozen could not be determined.A root cause cannot be determined.
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Manufacturer Narrative
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(b)(4).
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Event Description
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The complaint receiver device was returned for evaluation.The device was visually inspected and it passed.The receiver was able to be charged and rebooted.The receiver log was downloaded, firmware error was found.Functional testing was performed and there was no failure detected.The receiver case was opened and the internal inspection passed.The reported event of a frozen screen display was confirmed.The root cause could not be determined.
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Search Alerts/Recalls
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