Model Number 1000096 |
Device Problems
Vibration (1674); Data Problem (3196)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received.
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Event Description
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It was reported that the pump was vibrating despite the alerts and alarms settings being set to annunciate an audible tone.Additionally, the pump indicated a data log corruption.Blood glucose was 389 mg/dl.Reportedly, the customer had manual injections available as alternate insulin therapy.
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Manufacturer Narrative
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The failure investigation has been completed and the alleged speaker issue was verified.Additionally, based on the analysis, the alleged data error alert could not be verified.
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Search Alerts/Recalls
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