Based on the evaluation of data and limited information provided by the customer, the most probable root cause for contamination of the bact/alert® pf plus culture bottle with paenibacillus provecensis is human error (bottle handling) by the customer.Bact/alert® pf plus culture bottle instructions for use (ifu) ¿bottle preparation¿ section states "prior to inoculation, the culture bottle top needs to be disinfected with an alcohol swab or equivalent and allowed to dry." the contaminant (paenibacillus provecensis) found in the bact/alert® pf plus culture bottle at the customer site is a gram positive spore-forming rod, primarily found in the environment and is known to be a common blood culture contaminant, per published literature.Use of one disinfectant prep per bottle top aids in the removal of spores which are resistant to disinfectants.The mechanical wiping action of the disinfectant prep picks the spores up off the bottle stopper.In addition, the bact/alert® pf plus culture bottle ifu states care must be taken to prevent contamination of a venipuncture during inoculation into the culture bottles (e.G.Proper skin disinfection).Cumitech 1c 4 for the proper specimen collection techniques (referenced in the instructions for use) stresses that the disinfection of the venipuncture site is very important in order to reduce contamination.Contamination could lead to a specimen being determined positive when a clinically relevant isolate is not actually present.This situation occurred with the customer samples resulting in false positives by the contaminant of paenibacillus provecensis.There is no evidence of any bottle malfunction with the bact/alert® pf plus culture bottle lot.Monitoring and detection methods for potential bottle contamination are part of the manufacturing and quality control processes for bact/alert® culture bottles.The quality control bioburden results for bact/alert® pf plus lot 0004054746 were within the cfu/ml final release specifications.There is no indication that the manufacturing process of bact/alert® pf plus lot 0004054746 culture bottles contributed to the contamination issue as per the complaint by the customer.
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