MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® (TPSA) TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE

Model Number	10445090
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant falsely elevated total prostate specific antigen (tpsa) patient sample result was obtained on a dimension vista 500 system.The result was reported to the physician(s) who questioned the result.The same sample was reprocessed on an alternate non-siemens system and a lower result was obtained.No corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated total prostate specific antigen (tpsa) result.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated total prostate specific antigen (tpsa) patient sample result obtained on a dimension vista 500 system.Siemens healthcare diagnostics headquarters support center (hsc) has completed the investigation of the event.Hsc reviewed the information provided by the customer and the instrument data logs.Hsc concluded that this is not a tpsa assay or dimension vista 500 system issue.Tpsa quality control (qc) was within laboratory acceptance range on the date of testing.The event was caused by an interference in the patient's sample.The tpsa instructions for use (ifu) contain this statement: "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." there is no evidence of a potential product issue.The device is performing according to specifications.No further evaluation is required.Mdr 2517506-2022-00322 was filed for the same event.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® (TPSA) TOTAL PROSTATE SPECIFIC ANTIGEN 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: 15856240
• Report Number: 2517506-2022-00321
• Device Sequence Number: 20440310
• Product Code: MTF
• UDI-Device Identifier: 00842768016660
• UDI-Public: 00842768016660
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P000021/S013
• 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): 11/23/2022

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: 03/30/2023
• Device Model Number: 10445090
• Device Catalogue Number: K6451 SMN 10445090
• Device Lot Number: 22089BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2022
• 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: 59 YR
• Patient Sex: Male