[146102612]
A customer from the united states notified biom? Rieux of a patient's post-transfusion reaction. The platelet product had been tested with the bact/alert? Bpa culture bottle (ref 279018, lot 1052346) and obtained a potentially false negative result. On (b)(6) 2019, the recipient of leuko-reduced platelet product had a post-transfusion reaction. The product was cultured and found positive for streptococcus mitis (gram positive cocci in pairs and chains) in the aerobic bottle. The anaerobic bottle had no growth at five (5) days. Per the customer report, the platelet product had been collected from the donor on (b)(6) 2019 at the (b)(6) blood services collection and processing center. The bpa culture bottle was inoculated with the platelet product sample at the customer's center on day 3, approximately 72 hours after collection ((b)(6) 2019) and was entered in to the bact/alert 3d instrument immediately after inoculation. The bact/alert system reported a negative result on (b)(6) 2019. This negative culture bottle was discarded prior to the customer's notification of the transfusion reaction event. No subculture was performed on the bottle prior to discarding it. The platelet product donor was contacted after the event and denied any infection symptoms and denied being on antibiotics prior to the donation. The platelet bags were stored in an incubator at a temperature of 20- 24 c. Platelet bags were processed (plt count and splitting) only at the center, and no treatment was performed where it could inhibit co2 production. The patient's reaction did not have any lasting clinical affects. The patient's antibiotic coverage did not change because of the reaction. Also, the organism did not grow in patient's blood. At the time of this assessment, specimen collection and preparation techniques have not yet been provided by the customer. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5