Device Problem
Failure to Prime (1492)
|
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 prime (prime issue) issue.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 02/22/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/03/2017 with the following findings: the black box shows loss of prime warning associated with a low non-zero force.An ezprime and 24hr duration test were successfully completed with no loss of prime warnings being duplicated.The pump is detecting the correct force.Unidentified force low observed in the black box, force sensor calibration in specifications.Battery compartment is cracked below the bumper pad.Base crack observed between case seal and keypad.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
|