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

Catalog Number	08791732190
Medical Device Problem Codes	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's samples tested with elecsys total psa assay and elecsys free psa assay on a cobas 8000 e 801 module.This medwatch will apply to the elecsys total psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the elecsys free psa assay.The free psa (fpsa) value was greater than the total psa (tpsa) value.The tpsa results were 0.0294 ng/ml (accompanied by a data flag), 0.0229 ng/ml (accompanied by a data flag), and 0.563 ng/ml.The fpsa results were 0.584 ng/ml, 0.853 ng/ml, and 0.0413 ng/ml (accompanied by a data flag).
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields a2, a3a, and b7 were updated.Correction to the results in medwatch field b5, as the last total psa and free psa results were switched.The questioned results should be: the tpsa results were 0.0294 ng/ml (accompanied by a data flag), 0.0229 ng/ml (accompanied by a data flag), and 0.0413 ng/ml (accompanied by a data flag).The fpsa results were 0.584 ng/ml, 0.583 ng/ml, and 0.563 ng/ml.
Additional Manufacturer Narrative
Qc and calibration were acceptable.No pre-analytical issue was identified.Sample material was requested for investigation; however, it was not available.Therefore, further investigation could not be performed.A general reagent problem can be excluded, as the qc was within range on the date of event.The investigation did not identify a product problem.The cause of the event could not be identified.

• 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: 23829748
• Report Number: 1823260-2025-05174
• Device Sequence Number: 18463652
• Product Code: MTF
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Followup
• Report Date (Section B): 03/24/2026

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 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 02/27/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/28/2026; 03/24/2026
• 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
• Patient Age: 69 YR
• Patient Sex: Male