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.(b)(6).
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging that the battery compartment was 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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Follow-up # 1 device evaluation: the device has been returned and evaluated by product analysis on 2/17/2017 with the following findings: during visual inspection of the pump, it was observed that the battery compartment was cracked.The battery cap was not returned with the pump and a test cap was used to complete the investigation.
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Search Alerts/Recalls
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