H.6.Investigation: problem statement: customer reported complaint on bd multi-check control ivd having issues with the percent of cd4 events not within the range reported on reagent material # 3409127 lot# bm1120n on 04dec2020.Scope.The scope of issue is limited to part 340912 and lot bm1120n.Manufacturing defect trend: this product is manufactured by a third party.Manufacturing non-conformance data are not routinely available.Complaint trend: there is one complaint related to the reported complaint for the date range between (b)(6) 2019 and (b)(6) 2020.Batch history record (bhr) review: documentation for part 340912 and lot bm1120n was reviewed.The materials were found to have met all the manufacturing specifications prior to release.Retain sample evaluation / testing: the retain sample for part 340912, lot bm1120 was not tested prior to product expiry.Exp.Date 02dec2020.Returned sample evaluation: the sample was not requested to be returned because of product expiration.Exp.Date 02dec2020.Investigation result / analysis: the investigation was performed and based on the review of complaint trend, defect trend, bhr, root cause and risk analysis, the reported complaint was not confirmed.Risk analysis: hazard(s) identified? yes if no (to above), what actions will be taken? hazard #: _3.1.2 ¿ 3.2.3____.Hazard:_ _use error hazard___.Cause:_instability / improper storage / contamination _.Harmful effects: incorrect results, per assay value sheet, leads to a delay in results.Severity: __4____.Probability: __2___.Risk index: _8_____.Implementation: _in use stability study protocols; manufacturing procedures; qc testing protocols; ifu.___ risk control: _the design and development of the device will ensure that the process control works appropriately.All batches will be qc tested to ensure device is performing as intended; the ifu will provide instructions on how to properly use the device as intended; coa with incoming product at bd; qc testing results at supplier¿s.Effectiveness verification: _shelf life stability report; label approval process; _ new hazard: _no_.Mitigation(s) sufficient _yes__.Root cause analysis: based on the investigation result, root cause was not determined.Investigation conclusion: based on the investigation result, complaint was not confirmed.
|