Device Problem
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.(b)(6).
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a casing/condition (cracked/damaged casing) issue.It was alleged that the battery compartment was damaged.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit or cartridge compartment.
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Manufacturer Narrative
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Follow-up #1: date of submission 03/14/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/22/2017 with the following findings:
during investigation, the battery compartment was cracked on the side at the threads, and above and below the bumper pad.Unrelated to the original complaint, the display had a pink contrast.The base of the pump was cracked between the case seal and the keypad.The returned battery cap threads were stripped and a test cap was used for testing.
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Search Alerts/Recalls
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