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 a casing/condition (cracked/damaged casing) issue.It was alleged that the battery compartment was damaged.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 cartridge compartment.
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Manufacturer Narrative
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Follow-up #1: date of submission 03/06/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/15/2017 with the following findings: during investigation, the battery compartment was undamaged and the returned battery cap was intact and able to fit securely.Unrelated to the original complaint, the pump powered up with auditory and vibratory alarms to a blank screen.The pump cover was removed to find a shattered display screen.The blank screen failure was persistent with the use of a know working test display screen.An eeprom failure was concluded.Additionally, the keypad rubber was torn at the ok button.The keypad cover was removed to find no contamination or damage to the button contact.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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