Device Problems
Crack (1135); Battery Problem (2885)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The pump has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a power (battery life w/ damage) issue.It was reported that the battery compartment was cracked.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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Follow-up #1: date of submission 09/07/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/15/2016 with the following findings: investigation revealed a crack in the battery compartment.The pump powers on with intact auditory and vibratory features to a blank screen; therefore, investigators were unable to adequately investigate the reported ¿short battery life¿ complaint.Unrelated to the original complaint, corrosion was observed on the display screen inside the pump.A leak test failed due to a battery compartment leak.The pump¿s cover was removed and further moisture corrosion was found to the display screen and to the continuous glucose monitoring (cgm) module.
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Search Alerts/Recalls
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