Device Problem
No Display/Image (1183)
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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 display (blank screen) issue.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may result in an inability to use the product which may lead to long term cessation of delivery.
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Manufacturer Narrative
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The device has been returned and evaluated by product analysis on 01/26/2017 with the following findings: the original complaint of segments missing could not be duplicated or confirmed.Unrelated to the original complaint, the battery compartment was cracked and the battery cap threads were stripped.The cap was unable to fit to the returned pump or test pump, so a test cap was used.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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