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

Catalog Number K6451 SMN 10445090

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center (ccc) and reported a discordant, falsely elevated tpsa patient result obtained on a dimension vista 1500 instrument.Siemens headquarters support center (hsc) evaluated the information provided by the customer.The data is consistent with a heterophilic interference which is a limitation listed in the tpsa instructions for use (ifu).The tpsa 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." hsc requested the patient sample for investigation but no sample was provided.It was concluded that this was not an instrument issue.The event is consistent with the tpsa ifu labeling for the tpsa assay.No potential product issue identified.The instrument continues to be used without issue and the customer is satisfied with the tpsa assay performance.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.

Event Description

A discordant, falsely elevated total prostate specific antigen (tpsa) result was obtained on a patient serum sample on the dimension vista 1500 instrument.This result was reported to the physician (s).The same sample was reprocessed on an alternate siemens instrument on the same date and a lower, expected result was obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tpsa result.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® 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 ; 3026318356
• MDR Report Key: 9194569
• MDR Text Key: 177021638
• Report Number: 2517506-2019-00394
• Device Sequence Number: 1
• Product Code: MTF
• UDI-Device Identifier: 00842768016660
• UDI-Public: 00842768016660
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000021/S013
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2020
• Device Catalogue Number: K6451 SMN 10445090
• Device Lot Number: 19113BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2019
• 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: 68 YR