Device Problems
Crack (1135); 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 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.(b)(4).
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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 reported that the battery compartment was damaged.This complaint is being reported because the reported issue 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.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 09/02/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/06/2016 with the following findings: during investigation, a battery compartment crack was found on the left side of the grip pad.
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Search Alerts/Recalls
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