Device Problems
Break (1069); Circuit Failure (1089); Battery Problem (2885)
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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.(b)(6).
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a 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.
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Manufacturer Narrative
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Follow-up #1: date of submission 08/01/2016.Device evaluation: the device has been returned and evaluated by product analysis on 07/11/2016 with the following findings: during investigation, the battery compartment was found to be cracked.Unrelated to the original complaint, the audio bolus button cover was found to be damaged but still responsive during investigation.The pump case was found to be cracked.When the pump powered on, the display appeared dim and discolored.
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Search Alerts/Recalls
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