[141220380]
A customer in the (b)(6)contacted biom? Rieux to report the occurrence of little/no growth (false negative) for a candida albicans strain in association with the chromid? Candida media. The patient isolate was confirmed as candida albicans via maldi-tof test method. The customer stated that no incorrect result was reported to the treating physician, and that no patient harm or inappropriate treatment occurred. The customer indicated a delay of >24 hours to report a result due to additional testing required. The customer informed biom? Rieux that the chromid candida plates are routinely left in the lab on a rack for about five (5) hours during the day and the leftover plates are returned to the refrigerator. Per the chromid candida agar (can2) instructions for use....... This medium must not be exposed to light other than during the inoculation and reading steps. Allow reagents to come to room temperature in the dark. Inoculate the specimen. Immediately incubate the inverted plates in the dark at +37? C in aerobic conditions. The user is responsible for choosing the appropriate incubation temperature for the intended use, in accordance with current standards. The cultures are generally examined after 24, 48 hours of incubation, or even 72 hours depending on the type of specimen and the kind of microorganism being detected. The customer stated that, in spite of this instruction, the candida albicans ncpf 3255 growth control passed each day. The customer stated that the reported patient results were not affected by this issue. However the customer reported a delay of >24 hours between the time when the initial results should have been reported and the time when the repeat result was reported. 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