MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Catalog Number	08791732190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).
Event or Problem Description
There was an allegation of a questionable result not corresponding to the clinical picture for 1 patient tested for elecsys total psa (total psa) on a cobas e 801 analytical unit.On (b)(6) 2024, the patient had a total psa result from a siemens system of 10.31 ng/ml.On (b)(6) 2025, the patient had a result on the e801 analyzer of 4.21 ng/ml.The sample was repeated, and the result was 4.09 ng/ml.On (b)(6) 2025, the result from a new sample on the e801 analyzer was 1.79 ng/ml.The physician questioned how the result could change from 4.09 ng/ml in (b)(6) 2025 to 1.79 ng/ml in (b)(6) 2025 when the patient is not being treated for prostate cancer.The patient only takes rosuvastatin.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Liquid flow cleaning (lfc) was last performed on 02-jul-2025.No issues were identified during a review of the alarm trace data.The patient takes rosuvastatin.It was noted that statin use is associated with lower psa levels.The investigation did not identify a product problem.

• Brand Name: ELECSYS TOTAL PSA
• Common Device Name: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• 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: 22729596
• Report Number: 1823260-2025-02412
• Device Sequence Number: 8352441
• Product Code: MTF
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P990056/S039
• 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): 09/08/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 08791732190
• Device Lot Number: 82704401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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: ROSUVASTATIN
• Patient Age: 63 YR
• Patient Sex: Male