A customer in france notified biomérieux of observing a potential contamination with aspergillus fumigatus when using nucl.Lysis buf 2ml 48t (ref.(b)(4), lot number 22032403, expiry date 28-feb-2024).The customer stated that after swabbing, he found no aspergillus dna in the emag or in the room.He suspects the contamination comes from lysis buffer tube lot 22032403.The customer provided no further information on test runs performed using this lot.At the time of this assessment, the customer has not provided any clear information regarding any potential patient impact as a result of this reported issue.The customer reported the same issue on another lot 22033005 managed in complaint (b)(4).A biomérieux internal investigation was initiated.
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An internal investigation was opened following a notification from a customer in france regarding contamination with aspergillus fumigatus of nucl.Lysis buf 2ml 48t (ref.(b)(4), lot number 22032403, expiry date 28-feb-2024).Investigation results 1.Batch history record the batch history record did not highlight any issue during manufacturing of lot 22032403 of nucl.Lysis buf 2ml 48t (ref.(b)(4)).2.Complaint analysis no other complaint was recorded for lot 22032403 of nucl.Lysis buf 2ml 48t (ref.(b)(4)) for contamination issue.3.Tests performed no specific pcr against asp.Fumigatus was carried out in biomerieux facilities as this pcr is not available internally and since there is a backorder for this reference (competitor provider).3.1.Detection and identification of bacterial dna 16s tests for detection and identification of bacterial dna were carried out on lot 22032403 of lysis buffer: no abnormal level of signal was observed.Therefore no 16s contamination was detected for the tested lot.3.2.Decontamination of emag at customer site the customer performed emag system decontamination on site on (b)(6) 2023.A contamination test was carried out on (b)(6) 2023 and showed no contamination.4.Conclusion since 16s testing revealed no bacterial dna in the lysis buffer, and given that decontamination of the emag system at customer site resolved the issue, biomérieux suspects that the root cause of the observed false positive results was an emag system contamination, not related to the lysis buffer lot 22032403.For these reasons, there is no reconsideration of the performance of lot 22032403 of nucl.Lysis buf 2ml 48t (ref.(b)(4)).
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