Device Problem
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.
|
|
Event Description
|
On (b)(6) 2016, the reporter contacted animas, alleging the battery compartment was cracked.There was no indication that the product caused or contributed to an adverse event.This complaint is reportable as 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 08/23/2016.Device evaluation: the device has been returned and evaluated by product analysis on 07/29/2016 with the following findings: the battery compartment was observed to be cracked on the side from the threads traveling down along the side of the bumper to the case seal.The battery compartment was also cracked below the bumper at the case seal.
|
|
Search Alerts/Recalls
|