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

Catalog Number	09744860190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The total psa reagent expiration date was not provided.The cobas e 801 analytical unit serial number was (b)(6).The sample was discarded and is no longer available.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with total psa elecsys e2g assay on a cobas e 801 analytical unit, not matching the expected results.Initial result: <0.014 ng/ml.The initial result was reported to the physician as 0.014 ng/ml (not <0.014 ng/ml), and accompanied by "error 27".The result of 0.014 ng/ml was higher than the laboratory's rule of 0.006 ng/ml and was sent to the physician.It was considered inaccurate as the physician and the patient expected a result lower than the reportable range of <0.006 ng/ml.The sample was then repeated on a different instrument at the customer's site with a laboratory-developed test whose version had not been updated, and the repeat result was <0.006 ng/ml (accompanied by a data flag).The result of <0.014 ng/ml using the updated laboratory's rule was deemed to be correct.

• 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: 24715641
• Report Number: 1823260-2026-01130
• Device Sequence Number: 5763171
• Product Code: MTF
• UDI-Device Identifier: 07613336217665
• UDI-Public: 07613336217665
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 86528300
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/22/2026
• 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
• Patient Age: 79 YR
• Patient Sex: Male