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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of depressed advia centaur psa results which were discordant relative to alternate method testing while using lot 336.A depressed result was observed and not reported to the physician.The same sample was repeat tested on the original instrument and another depressed result (no details provided) was observed.For troubleshooting purposes, the same sample was also repeat tested on an atellica im analyzer which produced similar depressed result (no details provided).The sample was then tested using an alternate method and a higher result was obtained.The higher result was consistent with the patient¿s clinical condition and reported as correct to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed psa result.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of depressed advia centaur psa results which were discordant relative to alternate method testing while using lot 336.Quality control (qc) recovered within customer established ranges.Siemens is evaluating the event.
Additional Manufacturer Narrative
Mdr 1219913-2024-00343 was initially filed on 06-jun-2024.Additional information (27-jun-2024): siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states reported observation of depressed advia centaur psa results which were discordant relative to alternate method testing while using lot 336.Siemens evaluated the instrument data and the information provided by the customer.The calibration was valid and quality control (qc) was performing acceptably.The assay's instructions for use (ifu) provides the following warning, under intended use: "the concentration of total psa in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay for total psa used.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial levels of total psa is changed, the laboratory must perform additional testing to confirm baseline values".Advia centaur cp and atellica im psa assays are not standardized to the alternate-method test and the numerical results between the two methods are not expected to be identical.Also, the ifu indicates that (b)(4) of patients with prostate hypertrophy (bph) had psa results of 0.0- 4.0 ng/ml.Based on the available information and a review with medical affairs, the elevated psa result may not represent an analytical malfunction.A specific cause for the discordant results was unable to be determined.The issue was resolved by routine troubleshooting; a product problem was not identified.The customer is operational and no further actions are required.Note: in section h6, codes for investigation findings and investigation conclusions were updated.

• Brand Name: ADVIA CENTAUR PROSTATE-SPECIFIC ANTIGEN (PSA)
• Common Device Name: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney st.; registration #1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19476829
• Report Number: 1219913-2024-00343
• Device Sequence Number: 17910357
• Product Code: LTJ
• UDI-Device Identifier: 00630414203003
• UDI-Public: 00630414203003
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P950021/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 07/19/2024

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: 12/14/2024
• Device Model Number: N/A
• Device Catalogue Number: 10310292
• Device Lot Number: 336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2023
• 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 Age: 64 YR
• Patient Sex: Male