Device Problem
Failure to Prime (1492)
|
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
|
On (b)(6) 2016, the reporter contacted animas, alleging that there were loss of prime warnings.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
|
|
Manufacturer Narrative
|
Follow-up #1: date of submission 03/18/2016.Device evaluation: the device has been returned and evaluated by product analysis on 03/07/2016 with the following findings: investigators were unable to confirm or duplicate the original complaint; the black box data from the date of the complaint has been overwritten and no evidence of loss of prime was observed.A call service alarm 162 (no delivery, no prime) was observed in relation to a cartridge change.The ez-prime steps were performed correctly with no loss of prime occurrences or warnings.Upon removal of the pump cover, no intermittent condition was found to the force sensor circuit.Unrelated to the original complaint, the battery compartment was cracked and the display was dim and discolored.
|
|
Search Alerts/Recalls
|