(b)(4).The homechoice device was returned and evaluated by the product analysis lab (pal).A device history record review revealed no issues that could have caused or contributed to the reported issue.An internal/external inspection was performed and the device passed, along with all of the electrical testing.During the evaluation, the fluid was transferred outside of the returned instrument testing evaluation (rite) specified limits and the volumetric accuracy test that followed, showed that the device had failed.Pal performed a more detailed inspection of the door assembly.The inspection showed that the piston foam was deteriorated and the door piston was cracked.The results of the evaluation revealed the cause of the failure to be the deteriorated piston foam.The piston foam was to be scrapped and the device was sent for servicing.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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