H6.Investigation summary: the complaint investigation for discrepant results when using the bd max¿ exk¿ dna-1 kit (ref.(b)(4).) lot 3177555 was performed by the review of manufacturing records, review of customer¿s data and verification of complaints history.Review of the manufacturing records of the bd max¿ exk¿ dna-1 kit indicated that lot 3177555 was manufactured according to specifications and met performance requirements.Customer reported discrepant results when using bd max¿ exk¿ dna-1 kit from lot 3177555 with a pcr test from an external provider, (coccidioides pcr test).This test is not provided by bd.According to the customer, when tested on their instrument ct0168, the results exhibit ct values that are out of range, have shaky curves and are identified as positive results by the instrument.When tested on another bd max instrument (ct1723), the samples show flat curves, as expected, with no ct values and obtain a negative result.Customer provided database from instrument ct0168 for investigation.Manual pcr curve adjudication was performed.Analysis of some pcr curves from runs performed with the customer¿s coccidioides pcr test and the bd max¿exk¿dna-1 kit showed abnormal curves in the fam channel specifically on deck a, and showed curves that drift upward.Moreover, analysis of some runs performed with other tests also showed a low drift on deck a, when compared to deck b.Similar results were observed using at least 3 different bd max¿exk¿dna-1 kit lots.This analysis suggests that no specific lot is involved in the issue.A complaint is also opened on the customer¿s instrument.Overall, although bd is unable to confirm the cause of the current issue, based on the investigation results, the reagents are not suspected of being in cause.The investigation will continue through instrument complaint.Although not linked to the observed issue, it was noted that ct0168 used the software 5.10 and that a new version is available, it is recommended to upgrade the software version to 6.10.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿exk¿dna-1 kit lot 3177555.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa) since no new hazard was identified.Bd quality will continue to monitor for trends.H3 other text : see h10.
|