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

Model Number 10445091

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

Mdr 2517506-2021-00230 was filed for the same event.Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely elevated free prostate specific antigen (fpsa) patient sample result.Hsc reviewed the information provided by the customer and the instrument data log.Hsc observed that there was a non-linear analyte recovery upon dilution of the fpsa sample.This observation is consistent with the presence of a heterophile antibody potentially affecting the patient's fpsa result processed on the dimension vista system.There was no sample available for siemens evaluation.The dimension vista free prostate specific antigen (fpsa) 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." the device is performing within specifications.No further evaluation is required.

Event Description

A discordant falsely elevated free prostate specific antigen (fpsa) patient sample result was obtained on a dimension vista 500 system.The result was not reported to the physician(s).The same sample was reprocessed on the same system and a lower result was obtained upon dilution.The customer sent out 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 fpsa result.

• Brand Name: DIMENSION VISTA
• Type of Device: DIMENSION VISTA® (FPSA) FREE 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: 12377242
• MDR Text Key: 268466786
• Report Number: 2517506-2021-00229
• Device Sequence Number: 1
• Product Code: MTG
• UDI-Device Identifier: 00842768016677
• UDI-Public: 00842768016677
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020027/S009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Model Number: 10445091
• Device Catalogue Number: K6452 SMN 10445091
• Device Lot Number: 21095BC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 61 YR