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	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys total psa and elecsys free psa results for 1 patient sample on a cobas e 402 analytical unit.The elecsys total psa and elecsys free psa initial results were both marked by "samp.C" alarms.The sample was repeated.The elecsys free psa result was 0.922 ng/ml.The elecsys total psa result was 0.497 ng/ml.The technician observed red dots in the serum sample.On (b)(6) 2025, an aliquot of the sample was recentrifuged and tested.The elecsys free psa result was 0.187 ng/ml.The elecsys total psa result was 0.482 ng/ml.This medwatch will apply to the elecsys total psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the elecsys free psa assay.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration data for elecsys free psa shows 1 signal was out of range.The calibration data for elecsys total psa were acceptable.The qc was acceptable.A general reagent issue was excluded.The sample was not returned for investigation.The alarm trace showed a "sample clot detection" alarm, indicating a sample clot or insufficient sample volume was detected.The investigation determined the issue was due to a pre-analytical handling 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: 22805863
• Report Number: 1823260-2025-02482
• Device Sequence Number: 8950884
• Product Code: MTF
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (Y/N): N
• Initial Reporter Country: HO
• 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): 09/29/2025

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: 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): Initial
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/29/2025
• 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 Age: 33 YR
• Patient Sex: Male