A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The instrument was visually inspected.No abnormality was observed.Electrical resistance measurements indicate insufficient contact.When the instrument was opened, the contacts were not destroyed.Nevertheless, no defect contact points in the instrument could be identified.All contact points were specifically investigated but non of the contact points was loose.Based on the outcome of this investigation the complaint of the customer can be confirmed but the root cause could not be determined anymore.In production a 100% inspection of the instrument is performed which would identify defect contact points.Since the instrument passed this test, the contact must have been affected later.But this cannot be determined anymore.The root cause cannot be identified conclusively because the sample has pass the 100% inspection.As the blister was opened by the customer, he handled the product.The point in time when the malfunction occurred, can no longer be determent.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis the manufacturer internal reference number is: (b)(4).
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