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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys total psa results that were lower than their free psa results for 11 patient samples on a cobas e 801 analytical unit.Below are examples of three patient sample results that were provided by the customer.Sample 1 had an initial result of 0.044 ng/ml and a repeat result of 1.440 ng/ml.The sample had a free psa result of 0.431 ng/ml.Sample 2 had an initial result of 0.021 ng/ml and a repeat result of 1.480 ng/ml.The sample had a free psa result of 0.386 ng/ml.Sample 3 had an initial result of 0.019 ng/ml and a repeat result of 1.150 ng/ml.The sample had a free psa result of 0.205 ng/ml.The repeat total psa results were deemed correct.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.

• 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 -045
• 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: 50806939
• Report Number: 1823260-2026-03811
• Device Sequence Number: 10611130
• Product Code: MTF
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P990056/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 08791732190
• Device Lot Number: 88732702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• 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