MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION®; DIMENSION® TPSA TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE

Catalog Number RF451 SMN 10444889

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

Analysis of the information provided indicate that the cause for the discordant elevated tpsa result is unknown.No samples have been provided to siemens for investigation.Siemens headquarters support center has evaluated the information provided.The data is discordant high relative to the siemens alternate methodology, advia centaur.The instructions for use(ifu) for the dimension® tpsa flex® reagent cartridge contains the following information: "warning: the concentration of tpsa in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the psa assay used.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining psa levels serially is changed, additional sequential testing should be carried out.Prior to changing assays, the laboratory must confirm baseline values for patients being serially monitored." in the limitations of procedure section of the ifu it is also stated: "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.".

Event Description

A discordant elevated total prostate specific antigen (tpsa) result was obtained on a patient sample on the dimension exl system.The result was reported to the physician who questioned the result.The sample was tested with an alternate siemens methodology and a lower result was obtained.There are no reports of patient intervention or adverse health consequences as a result of the discordant elevated tpsa result.

Manufacturer Narrative

The original mdr 2517506-2017-00075 was filed 2/9/2017.Lot number corrected from ea7208e to ea7208.Udi number corrected from (b)(4).

• Brand Name: DIMENSION®
• Type of Device: DIMENSION® TPSA TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; glasgow business community; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6313764
• MDR Text Key: 66871714
• Report Number: 2517506-2017-00075
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000021/S002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2017
• Device Catalogue Number: RF451 SMN 10444889
• Device Lot Number: EA7208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2016
• 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