Device Problem
Inaccurate Delivery (2339)
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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 device 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 and alleged an inaccurate delivery issue.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because of the allegation against the injury delivery function of the pump.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 14-nov-2018 with the following findings: a review of the pump¿s black box showed that the pump was in use for deliveries until (b)(6)-2018; the original complaint of blood glucose issues was reported to occur on (b)(6)--2016.The pump history for 2016 was no longer available due to continued use of the pump.The current pump history showed no evidence of delivery malfunction.During investigation, the pump passed all delivery accuracy tests and was found to be delivering accurately and within range.The complaint of an inaccurate delivery issue was not able to be duplicated during investigation.Unrelated to the complaint, investigation revealed a crack in the battery compartment.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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