Device Problem
Temperature Problem (3022)
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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) 2016, the reporter contacted animas, alleging a temperature issue.No physical damage to the pump was reported.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 02-aug-2019 with the following findings: a review of the pump black box or download history showed any activity related to temperature issues.No sudden drop in voltage readings was observed.A visual inspection of the pump revealed no evidence of damage to the battery compartment or returned battery cap.There was no evidence of moisture contamination inside the battery compartment.The returned battery cap was able to fit securely to maintain an electrical connection.The pump powered on and was exercised for 12 hours with no warnings, overheating, or power loss duplicated.The pump electrical current draws were within specification.The pump¿s cover was removed and no evidence of moisture or defects were observed to the power components.The complaint of a temperature issue was not duplicated during investigation.There was no defect found.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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