Intended use: 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 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 of the issue: a customer in india notified biomérieux of having card termination issues with their vitek 2 compact (ref.27530, serial number (b)(4) resulting in delay in reporting results for twenty (20) patient isolates.The customer stated all cards loaded (b)(6) 2022 were terminated due to the optics being out of calibration.India local customer service (lcs) had the customer clean the optics and also connected to the system via remote diagnostics to check the optics status.The optics passed the cal command; however, the dac values were low.The values displayed with the read command were also low.Lcs determined the optics may need to be replaced.There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.This event was reviewed for vigilance reporting according to 21 cfr 803 concerning medical device reporting.Biomérieux vitek® 2 systems hazard definition states that injury or illness could result from a delay in the appropriate diagnosis or therapy, or result from continued administration of inappropriate antimicrobials or other potentially toxic therapies, due to a delay in determining the infecting agent's identification and susceptibility profiles.Therefore, a delay may exist in the therapy being initiated or tailored appropriately.In addition, the patient may be subjected to additional, possibly unnecessary diagnostics during the delay as a consequence of this hazard.Delays of longer than 24 hours may have a significant impact as the infection may worsen if there is a treatment failure.This review has determined that this event meets the criteria for reporting as a malfunction.Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur while testing a patient isolate.A biomérieux internal investigation will be initiated.
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A customer in india notified biomérieux of having card termination issues with their vitek 2 compact (ref.(b)(4).Serial number (b)(6) resulting in delay in reporting results for twenty (20) patient isolates.The customer stated all cards loaded (b)(6) 2022 were terminated due to the optics being out of calibration.The customer service identified errors-112 & 78 were present on the system.Investigation results complaint analysis.A complaint analysis has been performed for card terminated issues and transmittance calibration failure.No systematic quality issue related to these errors has been identified.No non conformities have been opened for issue related to the investigated complaint.No correctivce or preventive action has been opened for issue related to this complaint during the investigated time frame.Review of the customer log file.On (b)(6) 2022 errors 112 (optics almost out of calibration ¿ transmittance optics module tx3 nearing calibration limits) followed by error 78 (card terminated ¿ could not find the first edge of the card) occurred two times.The errors resulted in two incomplete (too short) card data packets and two test card terminations.The incomplete packets could not be processed by the vitek 2 system software and prevented all remaining test card data from updating.No new test cards were loaded on (b)(6) 2022.On (b)(6) 2022 a field service engineer logged onto the instrument via diagterm and tested the transmittance optics.All transmittance optics passed.All of the tx3 dac values of were significantly lower (suggesting the transmittance optics were replaced or cleaned).New test cards were loaded onto the instrument and carddata successfully processed through core.On (b)(6) 2022 ¿ (b)(6) 2022 multiple new test cards were loaded and card data successfully processed through the software.Note: on (b)(6) 2022 there was one error 78, however it occurred when a fse was logged onto the instrument.Error 112 did not occur.Conclusion.Customer service identified errors-112 & 78 were present on the system.The root cause of the vitek 2 system software handling of an incomplete card data packets is a software issue, fixed in 9mr3 software release which was launched to the field (b)(6) 2023.The csn issued date to field was (b)(6) 2022 and it includes the described fix relating to the incomplete data message handling (issue 11329).The root cause of error 112 , transmittance optics module tx3 nearing calibration limits, is due to either dirty optics or optics nearing its end of life.No optics were provided for this investigation, nor was it communicated if they were replaced.The root cause of error 78, ¿could not find the first edge of the card (terminated slot)¿, is the instrument unknowingly ejected a test card.Issue 1316 will be reviewed by the vitek 2 project team to determine when a fix can be implemented in a future vitek 2 systems software version.
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