MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PSA ELECSYS E2G; TOTAL PROSTATE SPECIFIC ANTIGEN TEST

Catalog Number	09744860190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys total prostate specific antigen (total psa) assay on a cobas e 801 analytical unit.Initial result: 0.6 ng/ml.On (b)(6) 2025: repeat result: 31.5 ng/ml.
Additional Manufacturer Narrative
The total psa reagent expiration date was not provided.The cobas e 801 analytical unit serial number was (b)(6).The qc was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Sections a2, a3a, b7, d4, and concomitant medical products were updated.Reportedly, an amended report with the result of 31.5 ng/ml was issued.The alarm trace showed abnormal aspiration alarms and sample foam detection alarms, indicating sample quality issues.The customer and service maintenance were completed per the specifications.A general reagent or analyzer problem can be excluded because the qc prior to the event was within the ranges.The investigation did not identify a product problem.The cause of the event was consistent with a preanalytic issue (too short centrifugation time) at the customer site.Preanalytics are within the customer's responsibility.

• Brand Name: TOTAL PSA ELECSYS E2G
• Common Device Name: TOTAL PROSTATE SPECIFIC ANTIGEN TEST
• 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: 22393423
• Report Number: 1823260-2025-02030
• Device Sequence Number: 13010360
• Product Code: MTF
• UDI-Device Identifier: 07613336217665
• UDI-Public: 07613336217665
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P990056
• 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): 07/24/2025

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 Catalogue Number: 09744860190
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; ATENOLOL; BIMATOPROST; CATHETER IN "SITU"; FINASTERIDE; OPTIVE FUSION; SIMVASTATIN; TAMSULOSIN
• Patient Age: 74 YR
• Patient Sex: Male