A customer in sweden notified biomérieux of obtaining incorrect gram stain results when using the previ® color gram (reference (b)(4) serial number (b)(4).Investigation: the investigator reviewed historical complaints and the device history record.There are no capas, nor non-conformities on vitek ms linked with customer complaint.On 07 dec21, local customer service (lcs) informed us that the customer canceled the return of previ color serial number sn (b)(6).During troubleshooting and preliminary investigation activities, there was no indication that the instrument was not performing as intended.It was not possible to define if there was an issue with this instrument since the instrument was not returned; therefore no additional investigation is possible for this case.In addition, the customer did not want to collaborate further to perform additional troubleshooting.On 20 dec 2021, lcs installed the instrument related to this investigation at another customer site, and the instrument functions as expected at this new customer site.This suggests user error at ¿norrlands university hospital¿ with their ¿manipulation¿ and/or ¿workflow¿.Conclusion: biomérieux complaints laboratory was unable to confirm or reproduce the customer¿s issue.Further investigation cannot be conducted without return of the device.
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