ACTIGRAPH LEAP

Description of Event or Problem

WE HAVE RECEIVED REPORTS OF LEAP 2.0 DEVICES EXPERIENCING AN INCREASE IN TEMPERATURE, INCLUDING THE THREE MOST RECENT SERIAL NUMBERS PROVIDED (LOT NUMBERS IN PARENTHESES): (B)(6) (0681), (B)(6) (0681), (B)(6) (0651). BASED ON OUR INVESTIGATION, WE DETERMINED THAT THE ELEVATED TEMPERATURE MAY ONLY OCCUR WHEN ALL THE FOLLOWING CONDITIONS ARE TRUE: (A) THE TOUCH SCREEN, TEMPERATURE SENSOR, AND/OR BAROMETER SENSOR WERE ALL ENABLED, (B) THE PLACEMENT OF THE TEMPERATURE SENSOR COMPONENT IS MISALIGNED IN THE MANUFACTURING PROCESS, (C) ENVIRONMENTAL FACTORS INDUCE AN ESD EVENT. NONE OF THE REPORTED ADVERSE EVENTS HAVE MET THE MANDATORY REPORTING REQUIREMENTS; SPECIFICALLY, THEY DO NOT MEET THE DEFINITION OF SERIOUS INJURY, AND NO MEDICAL ATTENTION WAS SOUGHT IN THE REPORTED CASES. ALTHOUGH THIS IS NOT A REPORTABLE EVENT, WE ARE SUBMITTING THIS REPORT FOR TRANSPARENCY AND AWARENESS. WE PERFORMED AN INVESTIGATION AND ROOT CAUSE ANALYSIS IN ACCORDANCE WITH OUR CORRECTIVE AND PREVENTIVE ACTION PROCEDURE. WE'VE RELEASED A FIRMWARE UPDATE TO MITIGATE THE ISSUE AND ARE ALSO ADDRESSING THE PROCESS ISSUE IN ASSEMBLY. WE ARE CONTINUING TO MONITOR THE EFFECTIVENESS OF OUR CORRECTIVE ACTION PLAN TO ENSURE EFFECTIVENESS. PT: 4582. DEVICE: 4030. REF: MW5188877, MW5188879.