Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Siemens healthcare diagnostics is investigating.The ifu states in interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
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Event Description
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Discordant advia centaur xp folate results were obtained on a patient sample between neat and dilution, the initial result was greater than 24 ng/ml.The sample was diluted and tested multiple times.The results were lower with dilution.The sample was tested again diluted on a second advia centaur xp and the result was lower than the neat result.The diluted results were considered correct.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant folate results.
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Manufacturer Narrative
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08/30/2017: additional information: there is no information on the patient medication.There is no new sample available for the patient to be tested.The patient sample (b)(6) was tested on an alternate method and the result was (b)(6).The testing on the advia centaur xp gave a mean result of 5.6 with a 20% cv after 1/5 or 1/10 dilution.Siemens is unable to determine the cause of the non-linear dilutions because there is no sample available to be returned.Additionally, there is no information about patient medication or if the patient had taken vitamins or supplements.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the limitations section: "hemolysis significantly increases folate values due to the high folate concentrations in red blood cells.Methotrexate and leucovorin interfere with folate measurement because these drugs cross-react with folate binding proteins.".
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Search Alerts/Recalls
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