(b)(4).The homechoice was returned for device evaluation for the reported issue of low voltage message.The reported issue was confirmed during an event history log review and sample analysis as a system error 1006.The assignable cause was determined to be the power supply.Full functional testing, electrical safety testing, calibration and simulated therapy were performed with no additional defects and malfunctions found with the device.Should additional relevant information become available, a supplemental report will be submitted.
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