Device Problems
Break (1069); Crack (1135)
|
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.(b)(4).
|
|
Event Description
|
On (b)(6) 2016, the reporter contacted animas, alleging a casing/condition (cracked/damaged casing) issue.It was alleged that the battery compartment was cracked.There was no allegation of an adverse event associated with this complaint.This complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit.
|
|
Manufacturer Narrative
|
Follow-up #1 date of submission 08/19/2016.Device evaluation: the pump has been returned and evaluated by product analysis on 07/28/2016 with the following findings: a visual inspection of the pump showed that the battery compartment was cracked.
|
|
Search Alerts/Recalls
|