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); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with elecsys total psa and elecsys free psa on a cobas e 801 analytical unit.This medwatch will apply to the total psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the free psa assay.No questionable results were reported outside of the laboratory as the results did not match the patient's clinical diagnosis.The sample resulted in total psa values of 0.10 ng/ml and 0.0972 ng/ml.The sample resulted in free psa values of 0.535 ng/ml and 0.530 ng/ml.The sample was treated with polyethylene glycol (peg) and the tests had a low recovery rate.Dilution studies showed abnormal recovery with the higher dilution ratios.No specific data was provided.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).Samples from the patient were provided for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Investigations of the patient's samples were able to reproduce the results obtained by the customer.When treated with a heterophilic antibody blocking tube, there was no evidence of heterophilic antibody interference.Spiking experiments determined the patient's sample contained an interfering factor against a component of the total psa assay.Per product labeling, "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." 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 issue.

• 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: 24898939
• Report Number: 1823260-2026-01456
• Device Sequence Number: 8859144
• 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): 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): 05/12/2026

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: 86528303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/12/2026
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian