Device Problem
Failure to Prime (1492)
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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.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 prime (prime issue) issue.There is no indication that the product issue caused or contributed to an adverse event.This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 08-jul-2019 with the following findings: during investigation, the complaint regarding prime issue was reported on (b)(6)2016 , according to the pump history the pump was in used until (b)(6) of 2019.Therefore all data from time of complaint has been overwritten.The available black box and pump history show no evidence of prime or delivery defects.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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