Device Problems
Moisture Damage (1405); Structural Problem (2506)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device 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 (b)(6) 2016, the reporter contacted animas, alleging a casing/condition (case damage with moisture) issue.It was alleged that the battery compartment was damaged and there was moisture in the pump.There was no indication that the product 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 12/12/2016.Device evaluation: the device has been returned and evaluated by product analysis on 11/18/2016 with the following findings: during investigation, moisture corrosion was found in the battery compartment.The battery compartment was cracked near the top left corner of the grip pad.A leak test was performed and failed due to a battery compartment crack.The pump was opened to find no moisture.Unrelated to the original complaint, the pump was unable to power on due to moisture corrosion in the battery compartment.The keypad buttons and the display were unable to be tested.
|
|
Search Alerts/Recalls
|