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); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
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 two cobas e 801 analytical unit analyzers.The free psa value was larger than the total psa value.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.The sample was tested three times on the first e801 analyzer, resulting in the following values: total psa = 0.172 ng/ml, 0.172 ng/ml, and 0.174 ng/ml, free psa = 0.203 ng/ml, 0.211 ng/ml, and 0.195 ng/ml.The sample was tested on the second e801 analyzer, resulting in the following values: total psa = 0.185 ng/ml, free psa = 0.191 ng/ml.
Additional Manufacturer Narrative
A serial number of (b)(6) was provided for one of the e801 analyzers.It is not known which of the two e801 analyzers this serial number applies to.The serial number of the other e801 analyzer was requested, but not provided.A sample from the patient was provided for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and controls were acceptable.A general reagent problem could be excluded.Investigations of the patient sample determined low concentrations of both total psa and free psa, with similar values.There was good recovery of both total psa and free psa when the sample was treated with a heterophilic antibody blocking tube and during spiking experiments with the sample.No obvious interfering substance or factor could be confirmed in the patient's sample.The investigation did not identify a product issue.
Additional Manufacturer Narrative
The patient had no history of surgery or related prostate disease.The patient did not present with any related clinical symptoms.

• 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: 23780728
• Report Number: 1823260-2025-05068
• Device Sequence Number: 13288233
• 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,Followup
• Report Date (Section B): 02/18/2026

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: 02/28/2026
• Device Catalogue Number: 08791732190
• Device Lot Number: 827044
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/25/2025; 02/02/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/18/2026
• 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