Device Problem
Retraction Problem (1536)
|
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 motor (rewind issue) issue.It was reported that the piston rod was not retracting.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the insulin delivery could be affected.
|
|
Manufacturer Narrative
|
Follow-up # 1 date of submission 2/07/2017 device evaluation: the device has been returned and evaluated by product analysis on 1/13/2017 with the following findings: a review of the pump¿s black box data did not find issues related to the complaint in the pump history.A rewind issue was not duplicated during the investigation.There were multiple ¿no cartridge detected¿ warnings observed in the pump's black box history.A load step malfunction was duplicated during the investigation.During the load step, the piston pushed up until the cartridge was empty.The force sensor calibration was found to be out of specification.The pump was opened and the force sensor pin was found to be cracked.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
|