MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PSA ELECSYS E2G; TOTAL PROSTATE SPECIFIC ANTIGEN TEST

Catalog Number	09744860190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable high total psa elecsys e2g results from the cobas e 801 analytical unit.The initial result was 100 g/l.The repeat result using a dilution was 5000 g/l with a data flag.On (b)(6) 2026, the sample was repeated using peg, and the result was 100 g/l.The physician believed that this was not reliable, especially as the patient didn't have any symptoms and was being tested as a routine check.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).Sample material from the patient was requested for investigation.
Additional Manufacturer Narrative
Additional information was received regarding the involved patient: based on the results, the patient was referred to the urology department and has since been diagnosed with metastatic prostate carcinoma.Initial radiology findings showed little cause for suspicion; however, metastases were subsequently identified on a bone scan.The psa level was checked and found to be 8159 g/l.It is unclear which platform was used for this measurement.The patient is currently being treated with apalutamide and firmagon.Medwatch fields b7 other relevant history and d10.Concomitant medical products and therapy dates were updated.The received patient sample material was tested, and the customer's results were confirmed.Based on the investigation results and the updated patient information, the investigation determined there was no malfunction of the device.No product problem was found.

• Brand Name: TOTAL PSA ELECSYS E2G
• Common Device Name: TOTAL PROSTATE SPECIFIC ANTIGEN TEST
• 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: 24427941
• Report Number: 1823260-2026-00651
• Device Sequence Number: 18217524
• Product Code: MTF
• UDI-Device Identifier: 07613336217665
• UDI-Public: 07613336217665
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/24/2026

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 Catalogue Number: 09744860190
• Device Lot Number: 887327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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: BISOPROLOL; IBUPROFEN; PANTOPRAZOLE; PARACETAMOL
• Patient Sex: Unknown