The Medical Devices Introductory Course 2020

Vigilance Q: Was the event caused by use error ?

G:It is not sufficient for a manufacturer to make an assumption that use error occurred. There must be some form of evidence, such as a statement from the complainant that the user did something which was not intended by us, and that this may be the cause of the event.

Ex: A complaint is received by the manufacturer of a blood collection tube relating to erroneous results for a particular test. The investigation reveals that the user routinely shakes the tubes vigorously to mix the sample with the additive before sending to the lab, and that this is probably the cause of the erroneous results. Since this should probably be considered use error, the event may not need to be reported.

The Organisation for Professionals in Regulatory Affairs

Vigilance

Q: Is the event associated with a significant increase in use error of this type ?

G: Even if the event was caused by use error and the manufacturer has evidence to support this, the frequency of events must be considered. If a specific use error is occurring with high or increasing frequency then a vigilance report may be required

Ex: If the same manufacturer had received an increasing number of complaints about erroneous results caused by vigorous shaking of the sample (use error), they should consider submitting a trend report (Note: PSR may be appropriate if agreed with the relevant CA)

The Organisation for Professionals in Regulatory Affairs