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	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a discordant elevated total prostate specific antigen (tpsa) patient sample result obtained on a dimension vista 1500 system.Siemens is investigating the event.Mdrs 2517506-2021-00236, 2517506-2021-00237, 2517506-2021-00238, 2517506-2021-00240, 2517506-2021-00241, 2517506-2021-00242, 2517506-2021-00243, 2517506-2021-00244, 2517506-2021-00245, 2517506-2021-00246 and 2517506-2021-00247 were filed for the same event.
Event or Problem Description
A discordant elevated total prostate specific antigen (tpsa) result was obtained on a patient's sample processed on a dimension vista 1500 system.The discordant result was reported to the physician(s).The result was questioned at a later date based upon subsequent tpsa sample results obtained for the same patient.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated tpsa result.
Additional Manufacturer Narrative
Additional information (06-oct-2021): siemens headquarters support center has concluded the investigation of the event.The customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a discordant elevated total prostate specific antigen (tpsa) patient sample result obtained on a dimension vista 1500 system.The same patient resulted with elevated tpsa results over multiple dates of testing.A review of the patient history showed consistent elevated tpsa results when processing tpsa on the dimension vista and lower tpsa results when processing with an alternate non-siemens methodology.The customer noted that the patient's result went up to >2000 ug/l when the patient was taking the natural supplements of gamma-linolenic acid (gla), eicosapentaenoic acid (epa), and cranberry.It was reported that the supplements did have a surfactant property that could cause increased binding of heterophilic antibodies.A sample from the same patient tested on (b)(6) 2021 was diluted and processed on a dimension vista system.The tpsa results showed the sample did not dilute linearly with the dimension vista tpsa assay which could be a potential indication of non-specific binding interference such as a heterophilic antibody or other autoantibodies.Quality control and calibration were within expectations indicating the assay was working as designed and the issue was specific to the patient.A patient sample was requested for siemens evaluation but none has been provided.The customer has declined to give further history concerning the patient medication and treatment.The interference described matches the presentation of non-specific binding such as seen with heterophilic interference or autoantibodies.This type of interference is known to occur in all forms of immunoassay and the assay instruction for use (ifu) contains the following cautions: "results of this test should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings." and "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 cause of the issue could be due to a potential patient specific heterophilic antibody interference, however that cannot be confirmed with the available data, therefore, the cause is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2021-00239 was filed 03-sep-2021.Mdrs 2517506-2021-00236, 2517506-2021-00237, 2517506-2021-00238, 2517506-2021-00240, 2517506-2021-00241, 2517506-2021-00242, 2517506-2021-00243, 2517506-2021-00244, 2517506-2021-00245, 2517506-2021-00246 and 2517506-2021-00247 were filed for the same event: one mdr was filed for each date of testing.Mdr supplements 2517506-2021-00236 supplement 1, 2517506-2021-00237 supplement 1, 2517506-2021-00238 supplement 1, 2517506-2021-00240 supplement 1, 2517506-2021-00241 supplement 1, 2517506-2021-00242 supplement 1, 2517506-2021-00243 supplement 1, 2517506-2021-00244 supplement 1, 2517506-2021-00245 supplement 1, 2517506-2021-00246 supplement 1 and 2517506-2021-00247 supplement 1 are filed for the same event containing this additional information.

• 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: 12421308
• Report Number: 2517506-2021-00239
• Device Sequence Number: 14614760
• Product Code: MTF
• UDI-Device Identifier: 00842768016660
• UDI-Public: 00842768016660
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P000021/S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: 01/10/2020
• Device Model Number: 10445090
• Device Catalogue Number: K6451 SMN 10445090
• Device Lot Number: 19010BA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR