Device Problems
Moisture Damage (1405); 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) 2019 the reporter contacted animas, alleging a casing/condition (case damage w/moisture) issue.It was alleged that the battery compartment was cracked with moisture ingress.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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Device evaluation: the pump has been returned and evaluated by product analysis on 16-jan-2020 with the following findings: a visual inspection of the pump indicated a battery compartment crack and moisture corrosion inside the compartment.Leak testing revealed leaks at the battery compartment crack and at the display lens seal.When the pump was opened, moisture corrosion was observed on printed circuit board components.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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