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 device 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) 2017, 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 05/18/2017.Device evaluation: the device has been returned and evaluated by product analysis on 05/03/2017 with the following findings: during investigation, the battery compartment was cracked from below the grip pad to the case seal.Unrelated to the original complaint, the pump powered up to a call service 069 alarm and was not able to recover from it.Investigation revealed that a language corruption occurred at a component on the printed circuit board resulting in a call service alarm.
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Search Alerts/Recalls
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