Device Problem
Structural Problem (2506)
|
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.(b)(6).
|
|
Event Description
|
On (b)(6) 2016, the reporter contacted animas, alleging a casing/condition (damaged cap and case) issue.It was alleged that the battery compartment cap was damaged and unable to be removed from the returned 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 03/24/2017.Device evaluation: the device has been returned and evaluated by product analysis on 03/06/2017 with the following findings: a visual inspection of the pump revealed no damage to the battery compartment.The battery cap was difficult to remove from the pump during investigation.The groove on the top of the battery cap was found to be worn.No other damage was observed.The battery cap contact height and width measurements were found to be within specification.
|
|
Search Alerts/Recalls
|