Intended use.Vitek® 2 systems and associated documentation are intended for laboratory use by trained, professional, clinical and industrial users.The vitek® 2 system is intended for the automated quantitative or qualitative antimicrobial susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, staphylococcus spp., enterococcus spp., streptococcus spp., and clinically significant yeast.The vitek® 2 system is also intended for the automated identification of most clinically significant anaerobic organisms and corynebacterium species, fermenting and non-fermenting gram-negative bacilli, gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.Description: a customer in (b)(6) notified biomérieux of obtaining delayed results using the vitek 2 v8.01 hp rp5810 pc wes7 (reference # 421648, serial number # (b)(4)) due to an internal system error (during view cassette).The customer stated that the delay was >24 hours because ast results were not available, and the customer was required to repeat ast for concerned isolates.There is no adverse event related to any patient's state of health.An investigation will be initiated.
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On (b)(6) 2020, a customer in france (crm 30855144 / (b)(6)) notified biomérieux that results for tested isolates/cards did not appear in the expected time frame in association with their vitek 2 systems (v2s) software.There were no errors displayed to the customer.The customer reported that setting up new cards and running test again did provide results.The issue began when the customer¿s system was at vitek 2 system software version 8.01 and continued after upgrading to vitek 2 systems software 9.02.The investigation identified (2) root causes: ¿ invalid certificates prevented vitek 2 software from contact with biomerieux user management (skeeper) when a cassette was processed.¿ error of the user for entering setup tech name incorrectly.This prevented the cassette (isolate) results from appearing in the v2s software.Global customer service (gcs) bulletin mar-4277, "vitek 2 systems 8.01 and higher-invalid security certificate - computer name or network configuration change¿ was issued on 17apr2019 to remind subsidiaries/distributors and customers about the instructions for modifying the pc hostname or network configuration.A software maintenance release (9mr2) was released to the field on 03aug2021 via customer service notification (csn 5259 ¿ vitek 2 systems 9mr2 maintenance release) to allow editing of the setup tech name in applicable scenarios.
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