The customer contacted a siemens customer care center (ccc) inquiring if there was a potential for carryover of emicizumab on the bcs xp systems.Siemens internal investigations revealed that there was a potential emicizumab carryover on patient samples for the low factor viii clotting applications.An urgent medical device correction (umdc) ph21-003.A.Us ("bcs xp system - potential carryover of emicizumab by patient samples") was sent to us customers and an urgent field safety notice (ufsn) ph21-003.A.Ous ("bcs xp system - potential carryover of emicizumab by patient samples") was sent to outside the us (ous) customers in march 2021.The umdc and ufsn explain that the bcs xp system may be affected by a potential emicizumab carryover on patient samples.Only the low factor viii clotting applications may be affected by this issue.Patient samples with factor viii concentrations above 15% of norm, measured in the normal factor viii clotting applications, are not affected.Siemens determined that an intensive washing after the measurement of an emicizumab patient sample can eliminate the potential carryover.Siemens recommends to measure patient samples with known emicizumab treatment in batch mode, followed by an intensive washing cycle of the sample probe using a washing solution.Additionally, results of hemophilia patients measured with any factor viii low application should be carefully reviewed considering clinical history.To date, there are no allegations of injury due to this behavior.
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