From the device history record, lot# 2508bq was manufactured on 31st aug to 06th sep 2018.No exception was recorded in the device history record that could lead to the reported incident.No sample was returned for investigation.Supplier reviewed the environment control, temperature/humidity, different pressure, air exchange time, particles, settling microbe, planktonic bacteria and surface microorganisms monitor/test record from jan 2018 to dec 2018, and all were within the specifications.There was no deviation found.According to the production environment control procedure, each workshop shall do the routine daily cleaning and comprehensive clean once or twice every week.From the investigation, the root cause could not be determined.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
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