MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® E2 ESTRADIOL FLEX® REAGENT CARTRIDGE

Model Number	10489099
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant falsely elevated loci estradiol (e2) result was obtained on a patient sample on a dimension vista® 500 intelligent lab system.The falsely elevated result was reported to the physician(s).The same sample was reprocessed on the same instrument, two alternate siemens instruments and on a non-siemens system.The reprocessed results from the alternate instruments were lower than the falsely elevated result and considered correct.The result from the non-siemens system was provided to the physician(s) on a corrected report.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated e2 result.
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely elevated loci estradiol (e2) result.Hsc reviewed the information provided by the customer.Quality control was in range and no issues were noted with other patient samples indicating that the dimension vista® 500 instrument and e2 assay were performing acceptably.Repeat processing of the same sample on alternate methodologies yielded lower expected results.Repeat processing of the same sample on the same dimension vista system yielded similar elevated results.Dimension vista loci estradiol (e2) flex reagent cartridge instructions for use 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.With the advent of new steroid based medications (analogues) with similar chemical structures to estradiol, there is the possibility of cross-reactivity and results inconsistent with the patients clinical history.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.If the estradiol results are inconsistent with clinical evidence, additional testing is suggested to confirm the result." the cause of the patient sample specific event is unknown.A potential product issue has not been identified.The device is performing within specifications.No further evaluation is required.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® E2 ESTRADIOL 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: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 15917259
• Report Number: 2517506-2022-00302
• Device Sequence Number: 12403086
• Product Code: NDR
• UDI-Device Identifier: 00842768026461
• UDI-Public: 00842768026461
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 12/05/2022

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: 01/24/2023
• Device Model Number: 10489099
• Device Catalogue Number: E2 K6463 SMN 10489099
• Device Lot Number: 22059BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2022
• 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: 58 YR
• Patient Sex: Female