Device Problem
Sticking (1597)
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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 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/unresponsive) issue.It was reported that all keypad buttons were under-responsive to user presses.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 09/19/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/26/2016 with the following findings: product evaluation was conducted and the alleged complaint could not be verified or duplicated.The keypad was intact with no evidence of peeling or damage and all keys were responsive.Upon removal of the keypad, no evidence of contamination was found on key contacts.The pump was opened up and evidence of corrosion was found on the display board and on the transceiver board.Unrelated to the original complaint, the audio bolus button cover was torn.The battery compartment was cracked.The battery cap threads were stripped and the cap was unable to tighten.A test cap was used to perform all testing steps.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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