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Grifols has received multiple reports of an increase in false positive (fp) results when using procleix ultrio elite ml 707983.The fp rates varied from 0.27% to 1.73% from 11 customers.The first customer that reported the issue was creative testing solutions (az, usa) where fps were detected indicating an unexpected rate.There are multiple cases for fps and grifols performed investigation to triage if it could be an instrument, lab contamination or assay related issue.Through internal testing performed on date 4apr2024, issues due to instrument and/or lab contamination were ruled out, and gds became aware of the potential product malfunction, as it was confirmed the relation of the ultrio lot 707983 with the alleged false positive increased rate.Later, in following days ten new complaints were captured in emea markets that led to the initiation of the mdr.Grifols quality assurance performed a review of the device history record for ultrio elite ml 707983.The ml passed all qc release testing and there were no reactive results during qc release specificity testing which is evaluated by testing 360 replicates of a negative serum panel.Furthermore, a review of the qc testing data confirmed that results were well below the s/co cutoff.Per the ultrio elite package insert (pi), nonspecificity after repeat testing for normal blood donors during verification and validation testing for the ultrio elite assay was 0.1% (0.05-0.2% with a 95% confidence interval).Grifols quality assurance performed investigation by testing 960 saline samples with ml 707983.Ten false positive results were observed, resulting in a false positive rate of 1.04% (0.47-1.73% with a 95% confidence interval).Although the sample size of grifols testing is still being increased, which can improve the fp rate, grifols considers that this may be a valid issue.The investigation is still in progress and updates will be provided when more information becomes available.The root cause and corrective or preventative actions are to be determined.Health hazard assessment:
fp result in a blood screening application can cause multiple retests (of pooled samples), removal of one or more donations from the blood supply or customer questions.An fp result can never lead to a management decision resulting in a life-threatening situation or deterioration of the health for the donor or the recipient of tested donations or transmission of infection.Increase in false positive results does not pose risks to the health or safety of patients.
risk assessment:
severity of a blood screening false positive result is considered minor.Probability of the false positive result is considered probable ('will occur several times during the defined time period') based on the complaint history of this lot (10 complaints out of 767k tests delivered).Overall risk is acceptable as per 04-03-12-sop and thus there is no significant impact on the benefit-risk analysis.Increase in positive results is not considered significant in comparison to the stated performance considering there is no significant impact on the benefit-risk analysis.A customer technical bulletin (ctb) has been drafted and will be distributed to all ultrio elite customers in the us who have received ml 707983, to inform customers about the issue and provide guidance on how to proceed forward.Mdr is submitted as a mechanism to communicate fda of this increased rate of false positives in ultrio elite lot 707983.
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