Model Number MT20649-1 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Dexcom was made aware on (b)(4) 2019, that on (b)(6) 2019, a transmitter failed error occured.No additional event or patient information is available.No product or data was provided for evaluation.The complaint confirmation of the reported unexpected receiver shutdown could not be determined.A root cause could not be determined.
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Manufacturer Narrative
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(b)(4).Describe event or problem - correction "dexcom was made aware on (b)(4)2019, that on (b)(6)2019, a transmitter failed error occured.".
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Event Description
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Dexcom was made aware on (b)(4)2019, that on (b)(6)2019, the receiver shut down unexpectedly.
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Manufacturer Narrative
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(b)(4).
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Event Description
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The product was evaluated.An external visual inspection was performed and it passed.The receiver failed to charge and reboot due to the receiver not turning on even with good battery.Receiver log download failed due to receiver not turning on.Log review not performed due to receiver not turning on.Receiver functional testing was unable to be performed.The receiver case was opened, and the internal visual inspection passed.The allegation was undetermined.The probable cause could not be determined.
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Search Alerts/Recalls
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