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

Model Number 10444889

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center (ccc) and reported a discordant, falsely elevated total prostate specific antigen (tpsa) patient result was obtained on a dimension exl 200 system.Siemens headquarters support center (hsc) evaluated the information provided by the customer.Hsc has determined that the customer had diluted the below assay range total prostate specific antigen (tpsa) patient sample 1:1 with a quality control (qc) material that had a mean recovery of about 18 ng/ml.The reprocessed result with the diluted sample was reported as approximately 9 ng/ml (9.15 ng/ml) to the urologist.The diluted patient sample recovery was half of the control material recovery which is consistent with the original sample processing recovery of < 0.13 ng/ml.This event is a customer use error and not a potential product issue with the dimension exl instrument or the tpsa assay.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 sample on a dimension exl 200 system.This result was reported to the physician(s).The same sample when first processed on the same day had recovered a below assay range value.The elevated result was not questioned.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tpsa result.

• Brand Name: DIMENSION®
• Type of Device: DIMENSION® 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
• 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: 9652921
• MDR Text Key: 194643386
• Report Number: 2517506-2020-00032
• Device Sequence Number: 1
• Product Code: MTF
• UDI-Device Identifier: 00842768013874
• UDI-Public: 00842768013874
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000021/S037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2020
• Device Model Number: 10444889
• Device Catalogue Number: RF451 SMN 10444889
• Device Lot Number: EF0240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2019
• 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