Device Problem
Inaccurate Delivery (2339)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
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
|
On (b)(6) 2016, the reporter contacted animas, alleging that the pump delivered insulin inaccurately.During troubleshooting with customer technical support, all of the pump's basal and bolus history added up to reflect the programmed rates and deliveries.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there is an allegation against the delivery function of the pump.
|
|
Manufacturer Narrative
|
Follow-up #1 date of submission 12/06/2016-correction to describe event or problem:
information was received from the reporter indicating that there was no malfunction of the pump, and the alleged issue was one related to use error.There was no indication that the product caused or contributed to an adverse event.
|
|
Manufacturer Narrative
|
The device has been returned and evaluated by product analysis on 4/04/2017 with the following findings: a review of the pump histories showed multiple manual suspends and manual resumes performed on the pump.A review of the total daily dose history indicated that the insulin delivery totals correctly reflected the programmed basal rate targets.The pump¿s ¿ez-prime¿ steps were performed correctly.The pump passed a delivery accuracy test and was found to be operating within required specification and delivery accurately.No defects were found on investigation therefore the investigation was unable to duplicate the initial ¿inaccurate delivery¿ complaint.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.(b)(4).
|
|
Search Alerts/Recalls
|