A customer in france notified biomérieux of experiencing an issue in which data was missing for cassettes after performing testing with their vitek® 2 v7.01 hp rp5810 pc wes7 (ref 420855, serial (b)(4)).The customer reported that they create vitek® 2 cassettes with the vitek® ms prep station.The customer set up virtual cassettes with cards on position 2, 4, 6, and 8 (4 different patients).The vitek® 2 incubated the cards without error, but the virtual cassette displayed in the vitek® 2 software only showed the card in position 8.The customer had to perform repeat testing for the cards that were in position 2, 4, and 6 and this led to a delay of > 24 hours in reporting results for three (3) patients.There is no indication or report from the customer that this event has led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
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This investigation was initiated due to a complaint from a customer in france using vitek 2 systems (8.01).The customer created two vitek 2 cassettes on (b)(6) 2021 with vitek ms prep station as virtual cassettes.One cassette had cards in position 2, 4, 6 and 8.The vitek 2 incubated cards without error, however the customer noticed this cassette in vitek 2 systems software only had one card in position 8.The remaining cards in positions 2, 4 and 6 were not displayed.A total of five (5) cards were reported a missing between the two cassettes.The customer processed new cards on (b)(6) 2021 which delayed results >24 hours.The root cause is user error.The cards reported as missing from both cassettes were determined to have been deleted by the customer thereby also removing the cards from the cassette.No corrective/preventive actions are required as the system is working as expected.
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