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.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging that the battery compartment was found to be cracked.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.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 02/21/2017 with the following findings: during investigation, the audio bolus button cover was found to be torn but still operable.Unrelated to the original complaint, the battery compartment was observed to be cracked.The returned battery cap had stripped threads.A test cap was used for testing.There was a base crack observed between the case seal and the keypad.
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Search Alerts/Recalls
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