[138520560]
A customer in the (b)(6) reported a false negative result for a patient sample from a genital swab, on chromid? Candida (can2) (lot 1006823440). The sample was positive on microscopic examination for yeast cells, but the culture was negative on can2 plates after 48 hours incubation. The microscopy examination and culture on can2 were repeated, along with culture on sabc (sabouraud dextrose agar chloramphenicol - oxoid) media. The microscopy was still positive for yeast cells. The sabc showed heavy growth of candida sp. One blue colony was present on the can2 plate, after 48 hours incubation. Additional testing was performed with can2 plates already in use, and can2 plates that were taken from boxes in the cold room of the same lot. The culture was also repeated with sabc plates. The repeat culture demonstrated a heavy growth of candida sp. On the sabc plates. The customer obtained just one blue colony on the can2 plate in use and no growth on the newer can2 plate. The two blue colonies were isolated on two different can2 plates were confirmed as candida sp. By performing a wet preparation and the observation of yeast cells. The customer stated that the patient results were not affected by this issue as they reported the result from the sabc plate. However the customer reported a delay of 48 hours between the time when the initial results should have been reported on (b)(6) 2018 and the time when the repeat result was reported on (b)(6) 2019. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5