Investigation: the patient was an 81-year-old male who presented with signs/symptoms of kidney stones and bacteremia.On (b)(6), 2024, a positive blood culture sample from the patient was tested on the biofire bcid2 panel.The biofire bcid2 panel reported enterococcus faecalis as detected.On the same day, the sample was retested on the biofire bcid2 panel.The biofire bcid2 panel reported e.Faecalis, s.Aureus, and staphylococcus spp.As detected.Gram-positive chains were observed on gram stain.E.Faecalis and s.Aureus were recovered from culture.The customer reported that due to the biofire bcid2 panel result, the patient's treatment may have been delayed.The customer stated that the patient's bacteremia was resolved.No serious injury or death was reported.Quality control (qc) records for pouch lot# 32kn23 (kit lot# 2635923) 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 s.Aureus result 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, s.Aureus on 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 29.Biofire bcid2 panel clinical performance summary, staphylococcus spp.Of the biofire bcid2 instructions for use (www.Online-ifu.Com/iti0048), the performance claim for the s.Aureus assay compared to standard manual and automated microbiological/biochemical identification methods showed an overall sensitivity of 100% (95% ci 97.6-100%) and an overall specificity of 99.9% (95% ci 99.5-100%).S.Aureus was detected in both false positive specimens using an additional molecular method.
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