MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR PSA ASSAY; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer has reported observation of falsely-elevated advia centaur xpt psa results for patients expected to produce results below detection limit.The customer indicates that psa results as high as 0.3 ng/ml have been seen for post-prostatectomy male patients and female patients, for whom results of <0.01 ng/ml were expected.No patient data were provided.There are no repoprts of patient intervention or adverse health consequences due to the discordant psa results.
Additional Manufacturer Narrative
A customer from outside the united states has reported observation of falsely-elevated advia centaur xpt psa results for post-prostatectomy male patients and female patients.Siemens has requested specific patient results, but has not received any details.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the ifu states: "warning - do not predict disease recurrence solely on serial psa values." "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." siemens is investigating.
Additional Manufacturer Narrative
Mdr 1219913-2022-00409 was initially filed on 2022-12-02.Additional information, 2023-02-24: siemens has concluded the investigation.A customer from outside the united states reported observation of falsely-elevated advia centaur psa results for postprostatectomy male patients and female patients.The customer indicates that psa results as high as 0.3 ng/ml have been seen for post-prostatectomy male patients and female patients, for whom results of <0.01 ng/ml were expected.No patient data were provided.The samples in question are not available for additional testing.Siemens made multiple requests for additional information in order to evaluate the reported issue, but received none of the requested information.The problem has been evaluated on the basis of the available information.It is noted that the customer used advia centaur psa kit lot 322 in combination with calibrator lot cq93.Customer bulletin 11641297, rev.A, 2021-04, "control system improvement for the centaur psa assay" communicates that a result bias is expected for the reagent-calibrator combination used by the customer.Following calibration of the assay using a recommended calibrator lot (cq96), the customer demonstrated within-range quality control (qc) results and acceptable patient correlation.Based on the available information advia centaur psa lot 322 is performing as intended, and a product performance issue has not been identified.The customer is operational and no further action is required.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ADVIA CENTAUR PSA ASSAY
• Common Device Name: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 15906445
• Report Number: 1219913-2022-00409
• Device Sequence Number: 5390573
• Product Code: LTJ
• UDI-Device Identifier: 00630414203003
• UDI-Public: 00630414203003
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P950021/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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: 03/24/2023
• Device Model Number: N/A
• Device Catalogue Number: 10310292
• Device Lot Number: 322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown