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.Initial reporter: (b)(6).
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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.The customer alleged that the battery compartment was found to be cracked.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 the cartridge compartment.
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Manufacturer Narrative
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Follow-up #1: date of submission 06/06/2017.Device evaluation: the device has been returned and evaluated by product analysis on 05/16/2017 with the following findings:during investigation, the battery compartment was cracked at the threads above the bumper traveling down and through the bumper to the case seal.The battery cap was returned stuck to the pump and had to be forcibly removed.The returned battery cap threads were damaged.Unrelated to the original complaint, the display was dim and fading pink.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
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Search Alerts/Recalls
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