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	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely elevated total prostate specific antigen (tpsa) patient sample result.Hsc reviewed the information provided by the customer and the instrument data log.Hsc noted that there was a non-linear analyte recovery upon dilution of the tpsa sample.This observation is consistent with the presence of a heterophile antibody potentially affecting the patient's tpsa result obtained on the dimension vista system.There was no sample available for siemens evaluation.The dimension vista total prostate specific antigen (tpsa) flex 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." the device is performing within specifications.No further evaluation is required.
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).The same sample was reprocessed on a later date and a lower result was obtained upon dilution.The customer sent the patient's sample to a reference laboratory for testing using a non-siemens methodology.A lower result, considered correct, was obtained and reported.There were no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated tpsa 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
• MDR Report Key: 12377241
• Report Number: 2517506-2021-00212
• Device Sequence Number: 14470060
• Product Code: MTF
• UDI-Device Identifier: 00842768016660
• UDI-Public: 00842768016660
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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: 04/16/2022
• Device Model Number: 10445090
• Device Catalogue Number: K6451 SMN 10445090
• Device Lot Number: 21106BA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR