Investigation: the patient was a 78-year-old who presented with increased lactic acid and white blood cell count at the time of testing.On (b)(6) 2024, a positive blood culture sample was tested on the biofire bcid2 panel.The biofire bcid2 panel reported all analytes as not detected.On (b)(6) 2024, the same sample was repeated on the biofire bcid2 panel.The biofire bcid2 panel reported e.Faecium and vana/b as detected.On (b)(6) 2024, the same sample was repeated again on the biofire bcid2 panel.The biofire bcd2 panel reported all analytes as not detected.On an unknown date(s), additional testing was performed on the same sample.Gram-positive cocci in chains were observed on gram stain.E.Faecium was recovered from culture, which was identified via microscan.The customer reported that the patient was not affected due to the false negative e.Faecium result on the biofire bcid2 panel.No serious injury or death occurred.The final diagnosis of the patient was endocarditis.Quality control (qc) records for biofire bcid2 panel pouch lot# 32sl23 (kit lot# 2678223) were reviewed.This pouch lot passed qc criteria and was found within specifications.The filmarray instrument (serial number# (b)(6) was working within designed specifications.Conclusion: the investigation concluded that the most likely cause for the false negative e.Faecium results on the biofire bcid2 panel was a pouch anomaly.Biofire is continuously monitoring the manufacturing process and has controls in place to ensure the product is manufactured to the highest quality.Each biofire reagent lot is qualified prior to product release; this qualification includes a high statistical-confidence sampling to confirm that the kit components released for customer use are conforming.All qc metrics for the pouch lot and instrument were met, and they passed qc.Review of the associated instrument showed the instrument was performing within specification and was not expected to have contributed to the discrepancies observed by the customer.Overall, e.Faecium on the biofire bcid2 panel has a false negative rate of <0.001 in the field over the last year.These rates are within biofire system specifications.According to table 27.Biofire bcid2 panel clinical performance summary, enterococcus spp.Of the biofire bcid2 panel ifu, the performance claim for the enterococcus faecium assay showed an overall sensitivity of 100% (95% ci 90.6-100%) and an overall specificity of 99.8% (95% ci 99.4-99.9%).Archived testing was not performed for e.Faecalis or e.Faecium.E.Faecium was detected in all three false positive specimens using an additional molecular method.
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