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	08/12/2022
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 total prostate specific antigen (tpsa) patient sample result obtained on a dimension vista 500 system.Siemens healthcare diagnostics headquarters support center (hsc) completed the evaluation of the event.No patient sample was provided to siemens for internal investigation.Hsc reviewed the information provided by the customer.The tpsa instructions for use (ifu) 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." hsc recommended using an alternate method for processing samples from this patient until the results are consistent with the patient's condition which would indicate there is no further interference.The ifu also states the following: "serum psa concentrations, regardless of the value, should not be interpreted as definitive evidence for the presence or absence of prostate cancer.Prostate biopsy is required for the diagnosis of cancer." hsc did not identify a potential product issue with the dimension vista tpsa assay.Tpsa quality control data (qc) indicates that the system is working as specified and the customer continues to report tpsa results without issue.The device is performing within specifications.No further evaluation is required.Mdr 2517506-2022-00246 was filed for the same event ((b)(6) 2017).Mdr 2517506-2022-00247 was filed for the same event ((b)(6) 2018).Mdr 2517506-2022-00248 was filed for the same event ((b)(6) 2019).Mdr 2517506-2022-00249 was filed for the same event ((b)(6) 2020).Mdr 2517506-2022-00250 was filed for the same event ((b)(6) 2021).
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 falsely elevated result was not reported to the physician(s).The same patient sample was reprocessed on an alternate siemens system.A lower result, considered correct, was obtained and reported.There were no known reports of patient intervention or adverse health consequences due to the falsely elevated dimension vista tpsa result.There are no customer allegations that the patient received unnecessary treatment due to the elevated result.

• 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: 15414305
• Report Number: 2517506-2022-00239
• Device Sequence Number: 12167488
• Product Code: MTF
• UDI-Device Identifier: 00842768016660
• UDI-Public: 00842768016660
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/13/2022

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: 05/05/2023
• Device Model Number: 10445090
• Device Catalogue Number: K6451 SMN 10445090
• Device Lot Number: 22125BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2022
• 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: 69 YR
• Patient Sex: Male