Model Number MODEL 250 |
Device Problems
Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2014 |
Event Type
malfunction
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Event Description
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It was reported that the patient's device has not been able to be checked because the physician's handheld has not been working.Further follow-up with the physician identified that an error executing run app message was observed.Troubleshooting was performed by performing a hard reset, but the message did not resolve.The flashcard was removed and reinserted and the device was powered off and then back on; however, the same message was received.Another hard reset was performed and the issue did not resolve.No additional relevant information has been received to date.
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Event Description
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The handheld and flashcard are expected to be returned, but have not been received to date.
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Event Description
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An analysis was performed on the returned programming handheld and flashcard.No anomalies associated with flashcard software were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.During the analysis of the handheld, it was identified that the handheld was unable to load the vns version 8.1 software.The cause for the anomaly is associated with a bent pin in the flashcard slot.Once the pin was straightened, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.
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Event Description
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The handheld, flashcard, and programming wand were received for analysis.Analysis of the programming wand was completed on 02/27/2015.The programming wand performed according to functional specifications.Analysis of the handheld and flashcard are underway, but have not been completed to date.
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Manufacturer Narrative
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New information received corrects the suspect device.
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Search Alerts/Recalls
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