A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Investigation: bd diagnostic systems (bdds) quality investigated the complaint of a potential false positive biofire test result when used with bd bactec¿ peds plus¿/ f culture vial.The biofire bcid identified proteus in a positive patient blood culture bottle with the results being reported out.The patient is (b)(6) in age and has been in the nicu since birth.The biofire results were reported to the caregiver, and the patient was treated with gentamicin and vancomycin based on the biofire results.Per the customer, the patient is in crisis in the nicu.Proteus did not grow in culture nor was it seen on gram stain.Bdds investigation findings to date are as follows: ¿ we have tested more than 400 samples for bioburden and/or molecular testing.¿ no viable proteus organisms have been recovered in any sample including raw materials, in-process water, the deionized (di) water system, and the environmental samples throughout the manufacturing process.¿ no proteus dna has been detected by molecular testing with biofire filmarray bcid assay in the water supply, the di water system and the environmental samples throughout the manufacturing process.¿ consistent with customer reports, some lots of final product tested positive for proteus sp with biofire filmarray bcid assay.¿ there have been no recent changes to raw materials, design, manufacturing process, or distribution practices.The remainder of bdds investigation will focus on the following areas: ¿ additional testing of the dehydrated media and the raw material components.¿ cross-reactivity evaluation of purified cultures of environmental organisms found during bioburden testing.¿ testing of additional in-process samples.Further actions are to be determined based on the remaining investigation results.
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It was reported that biofire identified proteus in a positive bd bactec¿ peds plus¿/ f culture vial.The patient is (b)(6) in age and has been in the nicu since birth.The biofire results were reported to the caregiver, and the patient was treated with gentamicin and vancomycin based on the biofire results.Per the customer, the patient is in crisis in the nicu.
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