MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP PSA ASSAY; PSA IMMUNOASSAY

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	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the falsely low non reproduced advia centaur xp prostate-specific antigen (psa) result is unknown.The customer's quality control results were acceptable at the time of the incident.Siemens is investigating.The instruction for use (ifu) under the intended use section states the following: "this in vitro diagnostic assay is intended to quantitatively measure prostate-specific antigen (psa) in human serum using the advia centaur®, advia centaur xp, and advia centaur xpt systems.This assay is indicated for the measurement of serum psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years and older.This assay is further indicated as an aid in the management (monitoring) of patients with prostate cancer." the instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instruction for use (ifu) under the limitation section states the following: "warning" "do not predict disease recurrence solely on serial psa values." "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.The concentration of total psa in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity.Total psa determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.".
Event or Problem Description
A false low advia centaur xp prostate-specific antigen (psa) result was obtained by the customer on a patient sample, and considered discordant compared to a higher psa result at an alternate laboratory and test method.The same patient sample had been sent to the alternate laboratory for free psa, and the laboratory also performed total psa testing that resulted higher.The following day, the customer performed daily system maintenance and quality control (qc) on the advia centaur xp system.The advia centaur xp psa was repeated using a different leftover sample tube from the same patient, and the result was higher compared to the initial result.The sample tube was re-centrifuged, tested in duplicate, and the psa results were also higher.A corrected report was issued by the customer.There are no reports that patient treatment was altered or prescribed of adverse health consequences due to the discordant advia centaur xp psa result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00224 on 11/15/2017 for a false low advia centaur xp prostate-specific antigen (psa) patient result.11/28/2017 - additional information: a siemens customer service engineer (cse) was sent to the customer site for system inspection, and replaced the aspirate probes on the instrument.The cause of the non-reproducible false low advia centaur xp prostate-specific antigen (psa) patient result may be attributed to the aspirate probes, however the initial false low result was not reproduced prior to the cse system inspection.The instrument is performing within specification.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP PSA ASSAY
• Common Device Name: PSA IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7033305
• Report Number: 1219913-2017-00224
• Device Sequence Number: 11198798
• Product Code: MTF
• UDI-Device Identifier: 00630414203003
• UDI-Public: 00630414203003
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P950021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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: 03/07/2018
• Device Model Number: N/A
• Device Catalogue Number: 10310292
• Device Lot Number: 032279
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1