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

Catalog Number	08828610190
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of 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 elecsys free psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the elecsys total psa assay.The free psa (fpsa) value was greater than the total psa (tpsa) value.The tpsa results were 1.22 and 1.33 ng/ml.The fpsa results were 1.98 and 1.87 ng/ml.The same sample was repeated after recalibration and on another module.The results remained the same; however, the actual values were not provided.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The affected patient sample was retested on another module: 14-jul-2025: the tpsa results were 0.944 and 1.03 ng/ml.The fpsa results were 1.67 and 1.71 ng/ml.The sample material was requested for internal testing, however, it was not available.Calibration and qc were found to be within the expected range.The instrument data did not reveal any issues.The investigation did not identify a product problem.A clear root cause of the event could not be determined as the patient sample was not available for further investigation.

• 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: 22628882
• Report Number: 1823260-2025-02303
• Device Sequence Number: 21100815
• Product Code: MTG
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/17/2025

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: 08828610190
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/17/2025
• 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