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

Catalog Number	09744908190
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	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about questionable results for 2 samples from the same patient tested with elecsys total prostate specific antigen (total psa) assay and elecsys free prostate specific antigen (free psa) assay on a cobas e 801 analytical unit.This medwatch will apply to the free psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the total psa assay.Sample 1: total psa: initial result: 0.0821 ng/ml.Free psa: initial result: 1.99 ng/ml.This free psa result was not reported outside the laboratory.The free psa result was greater than the total psa result, prompting the repeat of the sample the next day.The repeat results were identical to the initial results.On (b)(6) 2025, a new blood sample (sample 2) was taken from the patient and tested: total psa result: 0.0807 ng/ml.Free psa result: 1.99 ng/ml.Other total psa and free psa tests were performed at a different service laboratory using siemens atellica solution, resulting in the following: total psa result: 1.220 ug/l.Free psa result: 0.023 ug/l.These results were deemed to be correct.It is not known if sample 2 was repeated on siemens testing or if another new sample (sample 3) was drawn and tested on siemens testing.This information has been requested but not received yet.
Additional Manufacturer Narrative
The total psa reagent lot number was 865283 with an expiration date of 31-aug-2026.The cobas e 801 analytical unit serial number was (b)(6).Qc was within the assigned ranges on the day of sample measurements.The sample was received for investigation on 24-jul-2025.The investigation is ongoing.
Additional Manufacturer Narrative
Clarification: sample 2 was repeated on siemens at a different service laboratory.Calibration and qc data for the free psa and the total psa showed no abnormalities.Instrument-related information showed no alarms.The investigation of the returned patient sample confirmed the incorrect ratio of free psa/total psa > 1 on elecsys, which was alleged by the customer.The investigation results were consistent with the presence of an interfering substance affecting the decreased total psa concentration in the sample in question.The investigation did not identify a product problem.The cause of the event was consistent with an interferant.

• 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: 22612925
• Report Number: 1823260-2025-02296
• Device Sequence Number: 14798533
• Product Code: MTG
• UDI-Device Identifier: 07613336217672
• UDI-Public: 07613336217672
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 08/21/2025

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: 09744908190
• Device Lot Number: 832201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/21/2025
• 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