Investigation: the patient was a 16-year-old male who presented with signs/symptoms of postoperative would complications.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, a positive blood culture sample was repeated on the biofire bcid2 panel.The biofire bcid2 panel reported s.Aureus and staphylococcus spp.As detected.Gram-positive clusters were observed on gram stain and methicillin-susceptible s.Aureus was recovered from culture.It is unknown if the patient was impacted due to the biofire bcid2 panel result.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 (b)(4) 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 panel 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 (b)(4)) and an overall specificity of (b)(4)).S.Aureus was detected in both false positive specimens using an additional molecular method.
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