In design controls the verification step is very important. There is high risk factor if the device does not pass verification test. Though I have never personally encountered this kind of problem but, according to me the main issue that would occur is failure in software performance. So as a result there is a malfunction in a device that keeps humans safety at risk. And at the end this can call for recalls or removal of device. In this situation one option could be reevaluate and reexamine the whole device and process. Another option could be doing more tests of samples. After all this I would say that if it goes wrong do not go for major change you should understand the problem.