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

Catalog Number	08828610190
Medical Device Problem Codes	Incorrect Measurement (1383); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter questioned the results for 1 patient tested for elecsys free psa (free psa) and elecsys total psa (total psa) on a cobas e 801 analytical unit.This medwatch will cover free psa.Refer to medwatch with a1 patient identifier (b)(6) for information on the total psa results.The initial total psa result was 0.21 ng/ml.The initial free psa result was 10.50 ng/ml.The repeat free psa result was 11.70 ng/ml.A new sample was obtained, and the total psa result was 0.13 ng/ml.The free psa result was 8.50 ng/ml.The new sample was repeated by the siemens method, and the total psa result was 6.60 ng/ml, and the free psa result was 0.05 ng/ml.The customer suspects an interference affecting the roche results.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).
Additional Manufacturer Narrative
Section d4, expiration date was updated.Calibration and qc were acceptable.No abnormal trends were identified during a review of complaints related to free psa reagent lot 832201.Sample material was requested for investigation, but was not provided.As no sample material was available for the investigation, the cause of the event could not be determined.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.The investigation did not identify a product problem.

• Brand Name: ELECSYS FREE 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: 24121123
• Report Number: 1823260-2026-00211
• Device Sequence Number: 9371423
• Product Code: MTG
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P000027/S037
• 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): 03/25/2026

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: 03/31/2026
• Device Catalogue Number: 08828610190
• Device Lot Number: 832201
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 03/09/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/10/2026; 03/25/2026
• 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 Sex: Unknown