A siemens customer service engineer (cse) was sent to the customer site for system inspection.The cse performed a total service call that was acceptable.The acid pump, sample probe and guide for serum splatter were replaced, and the r3 probe calibration optimized.The cse ran ten sample replicates from five different patients successfully.The cause for the (b)(6) results is unknown.At the time of the event, the customer's quality control results for (b)(6) were within range.No conclusion can be drawn.The instruction for use (ifu) under the limitation section states the following: "for diagnostic purposes, the advia centaur hbsagii test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings." the instruction for use (ifu) under the interpretation of results section states the following: "if the sample is greater than 50 or flagged as "> index range," the specimen is reactive (positive) for hbsag, and no further testing is required.Note when the advia centaur hbsagii assay is used as a stand-alone assay (for example in pregnant women being screened to identify neonates who are at risk for acquiring hbv during the perinatal period), it is suggested that the advia centaur hbsag confirmatory assay be used to confirm the result." the instrument is performing within specifications.No further investigation is required.
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Siemens filed the initial mdr 1219913-2016-00080 on 05/19/2016 for (b)(6) advia centaur hbsag ii patient results, and mdr 1219913-2016-00080 supplemental report 1 on 06/24/2016 for a reagent lot number typographical correction.Update 07/02/2016: additional information: the customer sent the patient sample to another laboratory with an advia centaur system, and the (b)(6) result was (b)(6).The cause for the initially (b)(6) advia centaur hbsagii results is unknown.No conclusion can be drawn.The instrument is performing within specifications.No further investigation is required.
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