Investigation: the patient was a 68-year-old female.On (b)(6) 2024, the patient's 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, gram-positive clusters were observed on gram stain.On (b)(6) 2024, s.Aureus was recovered from culture and was identified via vitek® ms.The customer stated, on (b)(6) 2024, susceptibility testing showed mrsa and heterogeneous vancomycin intermediate s.Aureus (hetero-visa).On (b)(6) 2024, a repeat susceptibility testing showed mrsa and the sample was sent out for daptomycin susceptibility testing.The customer reported that due to the biofire bcid2 panel result, antibiotic treatment for the patient was delayed.The diagnosis of the patient was "adverse drug interaction with prescription infection associated with driveline.Follow-up infection associated with driveline." no serious injury or death was reported.Quality control (qc) records for biofire bcid2 panel pouch lot# 31w423 (kit lot# 2503423) 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 mrsa result 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, meca/c and mrej (mrsa) and s.Aureus assays had a false negative failure 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.According to table 65.Biofire bcid2 panel clinical performance summary, meca/c and mrej (mrsa)of the biofire bcid2 panel ifu, the performance claim for the meca/c and mrej (mrsa) compared to soc phenotypic ast methods showed an overall sensitivity of 91.9% (95% ci 82.5-96.5%) and an overall specificity of 98.0% (95% ci 92.9-99.4%).Isolates recovered from the five false negative specimens were identified as mssa by soc phenotypic ast methods.Isolates recovered from the two false positive specimens were identified as mrsa by soc phenotypic ast methods.
|