Device Problem
Crack (1135)
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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.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging the battery compartment was cracked.There was no indication that the product caused or contributed to an adverse event.This complaint is reportable as 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 08/31/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/08/2016 with the following findings: the battery compartment was observed to be cracked on the left side of the grip pad and below the grip pad.Unrelated to the complaint, the audio bolus button cover was punctured; however, the audio bolus button was responsive to button presses.Also unrelated to the complaint, the display was observed to be dim and pink.
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Search Alerts/Recalls
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