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 Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys total psa results from the cobas e 801 analytical unit for one patient.This medwatch will apply to the elecsys total psa (tpsa) assay.Please refer to the medwatch with a1 patient indentifier (b)(6) for the information related to the elecsys free psa (fpsa) assay.The initial tpsa result was 0.192 ng/ml, and the fpsa result was 9.96 ng/ml.The tpsa result on a siemens instrument was 6.71 ng/ml, and the fpsa result was 0.04 ng/ml.The tpsa result on (b)(6) 2026 on the e 801 was 0.174 ng/ml, and the fpsa result was 10.1 ng/ml.The tpsa result on (b)(6) 2026 on the e 602 was 0.160 ng/ml, and the fpsa result was 10.58 ng/ml.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The calibration and qc results were within specifications.The sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The patient's sample was received for investigation.The investigation confirmed the customer's results as a false low recovery of total psa.The investigation determined that the most likely cause is the presence of an unknown factor specifically preventing the recognition of the total psa antigen by the detection antibodies utilized by the tpsa assay.Per product labeling, "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." a general reagent problem of the total psa assay could be excluded.

• 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: 24260460
• Report Number: 1823260-2026-00392
• Device Sequence Number: 13203195
• 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): 04/23/2026

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: 865283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/23/2026
• 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: 68 YR
• Patient Sex: Male