The FDA public notice is at the link provided. The issue was with Abbot meters and the possibility for users to inadvertantly switch units of measure. The notice describes a corrective action to lock the units for the country of distribution for new units and to notify current users. SoftwareCPR Analysis: It appears to be an example where improved risk analysis accounting for use and misuse as well as identification of critical failure modes could have prevented these issues. It is another example where human factors and presuming use errors is seen as the manufacturer’s responsibility.
