[174470541]
On (b)(4) 2019, the customer reported that the bcid-gp panel (cartridge id c4000054839, lot # 53274702) reported no targets detected. Their standard-of-care algorithm identified streptococcus salivarius/vestibularis in subculture with identification by maldi-tof. As part of the investigation of the eplex bcid-gp panel discrepant result, the raw data from the eplex bcid-gp panel test run was analyzed indicating the streptococcus genus target had signal present but below the established assay cutoff. On (b)(4) 2019 (b)(4) customer technical support communicated this analysis to the customer. The customer followed up with (b)(4) customer technical support on (b)(4) and reported that the patient passed away. The customer stated that additional maldi-tof testing in conjunction with the eplex bcid-gp panel was taken into consideration for the patient treatment plan and that based on their lab's reporting protocol, their treatment plan was not affected by the eplex bcid-gp panel result. Internal review of qc data for the bcid-gp panel (lot 53274702) confirms that the affected lot appropriately met qc release specifications. Conclusion: review of the following information suggests that the bcid-gp panel performed as intended and within specification: review of the qc release data from the affected lot confirms that the lot successfully met the established qc release specifications. Review of the bcid-gp panel test run information demonstrates that the internal controls were valid. No run malfunction was observed and the eplex instrument (serial #1708100180) was working within design specifications. The investigation concluded that the most likely cause for this discrepant result was a difference in sensitivity between the eplex bcid-gp panel and the standard-of-care test methods. Background: the eplex bcid-gp panel streptococcus result is based on five assays: the species-specific streptococcus agalactiae, streptococcus anginosus group, streptococcus pneumoniae and streptococcus pyogenes assays and a broad streptococcus assay. The streptococcus salivarius organism is expected to be detected yielding an eplex streptococcus detected result. During panel development, four strains of streptococcus salivarius were tested to assess analytical reactivity and found to be inclusive at a concentration ranging from 1 x 10^8 to 4 x 10^8 cfu/ml (table 56, eplex bcid-gp panel package insert). Additionally, in silico analysis predicted detection for greater than 95% of target sequences for streptococcus salivarius and streptococcus vestibularis. (table 65, eplex bcid-gp panel package insert). The overall clinical sensitivity of the bcid-gp panel for detecting streptococcus was established to be 97. 4% (95% ci: 95. 0%-98. 6%). For clinical samples that contained either streptococcus salivarius or streptococcus vestibularis by the comparator test method, the eplex bcid-gp panel demonstrated robust performance with 100% sensitivity, including one sample that was polymicrobial (tables 43 & 53, eplex bcid-gp package insert). The investigation concluded that the most likely cause for this discrepant result was a difference in sensitivity between the eplex bcid-gp panel and the standard-of-care test methods. Incorrect results are an identified risk to health identified within fda class ii special controls guideline: multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures (may, 2015) and within (b)(4)'s product risk management file. The eplex bcid-gp panel was appropriately used according to the product's intended use, which describes the assay as an aid in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from the eplex bcid-gp panel are intended to be interpreted in conjunction with gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Patient Sequence No: 1, Text Type: D, B5