Siemens filed the initial mdr 1219913-2019-00104 on june 12, 2019.07/11/2019 additional information: the customer tested the patient sample number 7540620 on may 21st, 2019 at 19:46.The results were as follows: (b)(6) 2019 at 19:46 discordant result: 161.8 u/l.(b)(6) 2019 at 20:14 repeat result on the same system: 577.8 u/l.(b)(6) 2019 at 12:52 repeat result different advia centaur: 623.9 u/l.The sample was centrifuged at 4000 rpm for 10 minutes and was collected in sarstedt serum gel 7.5 ml tube.The sample was not respun.The customer reports a low discordant result on advia centaur xp total hcg (thcg) reagent lot 029305.A pregnant female tested on (b)(6) 2019 results lower than clinically expected for thcg.The same draw was repeated 2 days later without being respun and the thcg is higher matching clinical picture.The higher result was reproduced when sample was run on another advia centaur in the laboratory.There were no flags in the event log from the time when the low result was reported.The customer repeated other thcg samples from (b)(6) 2019 and evaluated thcg precision which was acceptable.This issue only affected this patient sample.Service was not sent in reference to this escalation since it was an isolated event.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the initially low thcg result, siemens cannot rule out pre-analytical factors or sample issue.A product non-conformance has not been identified.The instrument is performing within specifications.No further evaluation of the device is required.
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The cause for the discordant total hcg results is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the limitations section: "test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal non-pregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results - sometimes in consultation with other medical experts.".
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