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

Model Number	10444889
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center (ccc) and reported a discordant, falsely elevated 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 (9.63 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 or Problem 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 physician did not question the discordant falsely elevated result which was obtained on a dilution of the same sample made with a control material.A positron emission tomography (pet) scan was performed on the patient.There are no known reports of adverse health consequences due to the discordant, falsely elevated tpsa result or the pet scan.

• Brand Name: DIMENSION®
• Common Device Name: 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
• MDR Report Key: 9652926
• Report Number: 2517506-2020-00031
• Device Sequence Number: 1810924
• Product Code: MTF
• UDI-Device Identifier: 00842768013874
• UDI-Public: 00842768013874
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P000021/S037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2020
• Device Model Number: 10444889
• Device Catalogue Number: RF451 SMN 10444889
• Device Lot Number: BA0222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR