Device Problems
No Display/Image (1183); Moisture Damage (1405)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
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Event Description
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On (b)(6) 2019, the reporter contacted animas, alleging a display (blank screen w/moisture) issue.There is no indication the alleged product issue caused or contributed to an adverse event.This complaint is being reported because the issue may impact the user's ability to read some or all the information on the screen which may result in over or under delivery.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 22-aug-2019 with the following findings: during investigation, the pump fails to power on.Unable to investigate display issue due to no power.There was moisture in display.Pump case is cracked near top right corner of display.Pump leaks at crack in case.Pump opened; moisture damage found on pcb.No power due to moisture damage.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
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Search Alerts/Recalls
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