MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA®BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) FLEX® REAGENT CARTRIDGE

Catalog Number	K6430 SMN 10445107
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated beta human chorionic gonadotropin (bhcg) result obtained on a dimension vista® 500 intelligent lab system.Siemens is investigating the issue.Additional mdrs were filed for the events that occurred on (b)(6) 2023 and (b)(6) 2023.
Event or Problem Description
A discordant falsely elevated beta human chorionic gonadotropin (bhcg) patient sample result was obtained on a dimension vista® 500 intelligent lab system.The falsely elevated patient result was reported to the physician and was questioned.Additionally, a sample from the same patient was drawn and processed on an alternate dimension vista® 500 intelligent lab system on (b)(6) 2023 obtaining a falsely elevated result.A new sample was drawn from the same patient on (b)(6) 2023 and processed on the same dimension vista® 500 intelligent lab system, obtaining a falsely elevated result.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated beta human chorionic gonadotropin (bhcg) result.
Additional Manufacturer Narrative
Additional information (22-sep-2023): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the instrument data logs.No product non-conformance was identified with the beta human chorionic gonadotropin (bhcg) reagent or the dimension vista® 500 intelligent lab system.Quality control and calibration recovered within the expected ranges.No other patients were reported to have the same issue.Customer confirmed that the patient has not been back in to have more blood drawn for additional testing.Dimension vista bhcg instructions for use (ifu, 2019-06-14 j pn 10867659 ¿ us, ref (b)(4), issue date 14-jun-2019) states "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 customer did not send the sample to siemens for further investigation due to a sample stability issue, and no new sample was collected.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.Initial mdr 2517506-2023-00197 was filed on 19-sep-2023.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA®BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 17774490
• Report Number: 2517506-2023-00197
• Device Sequence Number: 6319884
• Product Code: DHA
• UDI-Device Identifier: 00842768015540
• UDI-Public: 00842768015540
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2024
• Device Catalogue Number: K6430 SMN 10445107
• Device Lot Number: 23115BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female