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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys total psa and elecsys free psa results from the cobas e 801 analytical unit that did not agree with the clinical status of the patient.An interference was suspected.This medwatch is for the total psa assay.Refer to the medwatch with a1 patient identifier (b)(6) for the free psa assay.The patient had been monitoring his results since 2015.The results have fluctuated over the years, but the total psa results were around 1.2-1.5 ng/ml, and the free psa results were around 0.18-0.2 ng/ml.Two years ago, the patient had an mri, which showed no changes.Within the past month, an mri revealed a lesion, and the biopsy confirmed the presence of a malignant tumor.The doctors believe the results should have been significantly higher based on the patient's mri and biopsy.The patient had a total psa performed at another laboratory, using abbott technology, and the result was 9 ng/ml.The following day, the total psa result using the cobas e 801 analytical unit was 1.79 ng/ml.A new sample was taken from the patient, and the total psa result was 1.87 ng/ml, and the free psa result was 1.17 ng/ml.Using a cobas pure at another laboratory, the total psa result was 1.78 ng/ml, and the free psa result was 1.04 ng/ml.Using an abbott anility at another laboratory, the total psa result was 11.07 ng/ml, and the free psa result was 1.37 ng/ml.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The second sample from the patient was submitted for investigation, and the customer's results could be confirmed.No interference in the sample could be identified.The investigation was unable to determine a specific root cause.A general reagent issue could be excluded as the calibration and qc were acceptable.

• 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: 23630308
• Report Number: 1823260-2025-04796
• Device Sequence Number: 9317344
• Product Code: MTF
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 01/30/2026

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: 08/31/2026
• Device Catalogue Number: 08791732190
• Device Lot Number: 86528302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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: ACARD; ADALAT; DALFAZ UNO; VALSACOR
• Patient Age: 75 YR
• Patient Sex: Male