Model Number 10445107 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An outside of united states (ous) customer contacted the siemens healthcare diagnostics remote service center (rsc) regarding a falsely elevated beta human chorionic gonadotropin (bhcg) result obtained on a patient sample on a dimension vista 1500 system.Siemens is investigating the event.Mdrs 2517506-2022-00266, 2517506-2022-00267, 2517506-2022-00268, 2517506-2022-00269, 2517506-2022-00270, 2517506-2022-00272 and 2517506-2022-00273 were filed for the same event.
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Event Description
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A discordant falsely elevated beta human chorionic gonadotropin (bhcg) result was obtained on a patient sample on a dimension vista 1500 system.The result was reported to the physician(s).New samples were processed on later dates on alternate non-siemens systems and lower, negative results were obtained, considered correct, and reported.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated bhcg result.
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Manufacturer Narrative
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Additional information (15-dec-2022): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and concluded the event was not due to any issue with the beta human chorionic gonadotropin (bhcg) assay.There is no evidence of a potential product issue.Hsc reviewed the patient bhcg testing history and noted the consistently elevated bhcg results over multiple sample draws for the patient.A heterophile blocking study performed by the customer verified the presence of a non-specific binding interferent such as a heterophile antibody.The cause of the event is isolated to a patient specific issue.As stated in the limitations of procedure section of the dimension vista bhcg flex reagent cartridge instructions for use (ifu): "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution." the device is performing according to specifications.No further evaluation of this device is required.Section h6 has been updated to reflect siemens' investigation.Initial mdr 2517506-2022-00271 was filed on 07-oct-2022.Mdrs 2517506-2022-00266, 2517506-2022-00267, 2517506-2022-00268, 2517506-2022-00269, 2517506-2022-00270, 2517506-2022-00272 and 2517506-2022-00273 were filed for the same event.Mdr supplements 2517506-2022-00266 supplement 1, 2517506-2022-00267 supplement 1, 2517506-2022-00268 supplement 1, 2517506-2022-00269 supplement 1, 2517506-2022-00270 supplement 1, 2517506-2022-00272 supplement 1 and 2517506-2022-00273 supplement 1 were filed for the same event.
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Search Alerts/Recalls
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