Device Problem
Device Slipped (1584)
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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 been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion 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 casing/condition (external component issue) issue.It was reported that the battery cap had stripped threads.There is no indication that the product issue 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 cap.
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Manufacturer Narrative
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Follow-up #1: date of submission 08/22/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/02/2016 with the following findings: during investigation, the battery cap was found to be damaged.The threads were noted to have been stripped and torn.The battery cap was difficult to attach and did not fully tighten to the test pump.The yellow o-ring was visible.Unrelated to the original complaint, there was visible rust on the battery cap.
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Search Alerts/Recalls
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