Device Problems
Moisture Damage (1405); Structural Problem (2506)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The pump has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
|
|
Event Description
|
On 11/06/2016, the reporter contacted animas alleging a casing/condition (case damage w/moisture) issue.It was reported that the battery compartment was cracked and there was moisture present in the pump.There is no indication that the product issue caused or contributed to an adverse event.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 or cartridge compartment.
|
|
Manufacturer Narrative
|
Follow-up # 1 date of submission 2/03/2017.Device evaluation: the device has been returned and evaluated by product analysis on 1/16/2017 with the following findings:
during visual inspection of the pump, it was observed that the battery compartment was cracked and there was evidence of moisture in the compartment.A leak test was performed and failed due to the battery compartment leak.The pump was opened and there was no further moisture found internally.
|
|
Search Alerts/Recalls
|