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Would this be FDA reportable?

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Hello everyone,


It was discovered during a monthly audit that tach and timer testing was not done for our serofuges during the quarterly timeframe.  The audit was done late so this omission was not discovered until about 2 months after the testing should have been done.


All implicated serofuges were immediately removed from service upon discovery.


Is this reportable to the FDA?

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If you finally did them and the settings hadn't changed then there is no compromise of testing which would affect the purity, potency, . . . and I would not report this. If, however, there were major changes in the rpms or timer (if it is digital you don't need to check the timer), then, in my opinion, you would have a reportable event AND would probably have to repeat any testing done in the interval that was missed (which would be rather difficult I imagine).

Just my opinion.

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Assuming that the serofuges in question refer to ones used for pre-transfusion testing of patient specimens, I would not report this to the FDA. FDA reportable events are ones that may have affected the safety, purity or potency of a distributed blood product. This applies both to transfused products and products that were in control of the BB/TS at the time of the deviation. I do not think your situation applies. Granted, the safety, purity or potency of the product may have been affected if you mistyped a patient due to improper centrifugation, but I think that's a stretch.

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