MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP PSA; PROSTATE SPECIFIC ANTIGEN ASSAY (PSA)

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens field service engineer (fse) was sent to the customer site.The fse performed a total service call and no issues were identified.The instrument was then calibrated with all new advia centaur psa lot 281 material and the mcms passed indicating lot 281 is performing as intended.The patient correlations after service and with all new advia centaur psa lot 281 material were acceptable to the customer.The cause of the high bias the customer originally had with the advia centaur psa lot 281 cannot be determined since new material was used after the instrument was serviced.Based on the available information, the advia centaur psa lot 281 is performing as intended.The cause for the discordant advia centaur xp psa results is unknown.The instrument is performing within specification.No further evaluation of the device is required.The ifu states in the limitations section: "note: do not interpret levels of psa as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed prostate carcinoma frequently have levels of psa within the range observed in healthy individuals.Elevated levels of psa can be observed in patients with nonmalignant diseases.Measurements of psa should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".
Event or Problem Description
Discordant high advia centaur xp psa results were obtained for samples from three patients when correlating reagent lot 277 and 281.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant psa result.

• Brand Name: ADVIA CENTAUR XP PSA
• Common Device Name: PROSTATE SPECIFIC ANTIGEN ASSAY (PSA)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7067599
• Report Number: 1219913-2017-00227
• Device Sequence Number: 1357752
• Product Code: MTG
• UDI-Device Identifier: 00630414202990
• UDI-Public: 00630414202990
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P950021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2018
• Device Model Number: N/A
• Device Catalogue Number: 10310293
• Device Lot Number: 89916281
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1