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 a history settings (inaccurate delivery) issue.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported based on the allegation against the delivery function of the pump.
|
|
Manufacturer Narrative
|
Device evaluation: the device has been returned and evaluated by product analysis on 03/22/2017 with the following findings: the black box begins on (b)(6) 2017.Due to continuous use of the pump the black box data/histories for the event have been overwritten.Available daily insulin delivery totals correctly reflect the users programmed basal rates.The pump passed delivery accuracy test and was found to be delivering within required range and delivering accurately.Unable to duplicate the complaint, the pump information for the complaint date has been overwritten.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.
|
|
Search Alerts/Recalls
|