(b)(4).The homechoice device was returned and evaluated by the product analysis lab (pal).A service history review was performed and revealed no issues that could have caused or contributed to the reported issue.An internal and external inspection was performed and no issues were noted.Temperature verification was performed, and the device passed all testing pertaining to temperature verification.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.The device was determined to meet electrical performance specification requirements per rite testing, but failed rite functional testing due to the device not meeting volumetric accuracy specifications.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.Upon completion of the investigation, the cause of the failure was verified to be the deteriorated piston foam and cracked door piston.Both the piston foam and the piston door were replaced.Should additional relevant information become available, a supplemental report will be submitted.
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