Device Problem
Inaccurate Delivery (2339)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The reporter contacted animas on (b)(6) 2016 alleging the pump demonstrated an issue with inaccurate delivery, that the "base flow blocked after several hours." animas customer technical support made several attempts to follow up with the reported for more information regarding this alleged issue, but the reporter did not respond to those attempts.There was no reported adverse physical event associated with this complaint.This complaint is being reported because the alleged remained unresolved.
|
|
Manufacturer Narrative
|
Follow up #1 submitted: 04/22/2016.Due diligence follow up information revealed that the complaint did not involve an "inaccurate delivery issue" with the pump.The reporter confirmed that the complaint was of a different nature that will be reported on a separate individual report.
|
|
Manufacturer Narrative
|
Follow up #2 submitted 04/22/2016.Due diligence follow up revealed that the user alleged random call service alarm 064 or occlusion alarms with infusion set tubing/site.Instructions were followed for insertion of the infusion set.This complaint is being reported because the alleged occlusion issue remained unresolved.
|
|
Manufacturer Narrative
|
Follow-up #1: date of submission 05/26/2016.Review of the black box data revealed the last basal delivery was on (b)(6) 2016@6:51pm.Multiple basal delivery interruption caused by power interruptions are observed from (b)(6) 2016@7:49pm.From (b)(6) 2016@2:42pm.The basal program was manually cleared and the pump was running on a 0.00 unit per hour empty basal program for 16 days from (b)(6) 2016@08:35am.The total daily doses add up correctly and reflect the programmed basal rate target.No battery cap was returned.The battery compartment was undamaged and a test cap is able to fit to maintain electrical connection."ez-prime" steps were performed; the pump reflected 24 units after 24 hours on 1.0 unit per hour duration test.No delivery interruptions occurred during the investigation.The product performed within the required specifications.Investigation did not duplicate the "inaccurate delivery" complaint.
|
|
Search Alerts/Recalls
|