However, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.If the picture the customer sent in was followed the complaint would not meet spec.But technically it is impossible that this mix-up of lots did occur.The customer received both lots.The root cause of the mix-up is likely to be at the customers end.A dhr review was conducted with no discrepancies noted.
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