Device Problems
Moisture Damage (1405); Failure to Read Input Signal (1581)
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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) 2016, the reporter contacted animas, alleging a button/keypad (tactile changes w/moisture) issue; moisture behind the display and response issues with up arrow, down arrow and ok buttons.This complaint is being reported because the issue has the ability to result in inadvertent or incorrect insulin delivery or the inability to use the pump.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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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.Device evaluation: the device has been returned and evaluated by product analysis on 12/10/2016 with the following findings: on investigation, there was moisture behind the display lens.The pump would not power on for testing.Leak testing revealed a leak at the display lens.The keypad was intact and without damage.The keypad cover was removed for investigation and revealed no contamination on the contacts of the keypad buttons.There was moisture throughout the pump interior compartment including the keypad flex connector.Product analysis was unable to test the keypad button response because the pump failed to power on for testing due to the moisture damage.
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Search Alerts/Recalls
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