Device Problems
Electrical /Electronic Property Problem (1198); Structural Problem (2506)
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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 power (damage) issue.It was alleged that the battery compartment was found to be cracked.There was no allegation of an adverse event associated with this complaint.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
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Manufacturer Narrative
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Follow-up #1: date of submission 03/10/2017 device evaluation: the device has been returned and evaluated by product analysis on 02/16/2017 with the following findings: a review of the black box showed one power on reset event.The battery compartment was cracked at the threads to the left side of the grip pad down to the seal, and from the case seal to the grip pad.The battery cap was able to fit for testing.The intermittent power complaint was no duplicated during the investigation.The rewind, load, and primes steps were performed successfully.The pump was run for 24 hours and no loss of power issues occurred.The pump was opened to find moisture in the battery canister and near the power printed circuit board.Unrelated to the original complaint, the keypad was torn.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.(b)(4).
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Search Alerts/Recalls
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