MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA; TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Catalog Number	07027966190
Medical Device Problem Codes	Signal Artifact/Noise (1036); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The samples have been requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys total psa results from the cobas e 801 analytical unit.This medwatch will apply to the elecsys total psa assay.Please refer to the medwatch with a1 patient identifier (b)(6) for the information related to the elecsys free psa assay.Patient 1's free psa result on (b)(6) 2025, was 3.33 ng/ml, and the total psa result was 2.46 ng/ml.A new sample was requested on (b)(6) 2025, and the free psa result was 2.48 ng/ml, and the total psa result was 1.78 ng/ml.Patient 2's free psa result on (b)(6) 2025, was 0.798 ng/ml, and the total psa result was 0.220 ng/ml.Patient 3's free psa result on (b)(6) 2025, was 0.332 ng/ml, and the total psa result was 0.903 ng/ml.
Additional Manufacturer Narrative
Two samples were received for investigation.The investigation determined that the root cause is the presence of interfering substance or substances in the elecsys total psa assay.No product issue was found as the confirmed and possible interferences are dislcaimed in the method sheet for this assay.

• Brand Name: ELECSYS TOTAL PSA
• Common Device Name: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22106088
• Report Number: 1823260-2025-01653
• Device Sequence Number: 7275671
• Product Code: MTF
• UDI-Device Identifier: 04015630939824
• UDI-Public: 04015630939824
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P990056
• 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): 09/05/2025

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 Catalogue Number: 07027966190
• Device Lot Number: 781995
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1 - COMBODART; PATIENT 1 - LOSARTAN; PATIENT 2 - ATENOLOL; PATIENT 2 - DARFLON; PATIENT 2 - GLIFAGEN; PATIENT 2 - LOSARTAN; PATIENT 2 - PANTOPRAZOLE; PATIENT 2 - ROSUVASTATIN; PATIENT 2 - SOMALGIN
• Patient Sex: Unknown