A sample and pictures were returned for investigation.The pictures showed that the blue chip was missing; no other discrepancies were found.A functional test was performed, and no discrepancies were detected.The product primed without difficultly.The reported failure was not confirmed.The root cause cannot be determined as no fault was found.A device history review (dhr) was performed, and no problems or issues were identified during this dhr review.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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