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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys total psa (total psa) assay and free psa assay results from one patient sample tested on the cobas e 801 analytical unit.This medwatch is for the elecsys freel psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for the elecsys total psa (total psa) assay.Total psa: the initial result from the analyzer was 0.282 ng/ml.The repeat result from a competitor analyzer was 2.183 ng/ml.The patient sample was diluted with increasing amounts of negative serum, as the result was lower than the level of detection (lod).The repeat result at 1:2 dilution was 0.143 ng/ml.The repeat result at 1:4 dilution was 0.0787 ng/ml.The repeat result at 1:8 dilution was 0.0418 ng/ml.Free psa: the initial result from the analyzer was 1.21ng/ml.The repeat result from a competitor analyzer was 1.403 ng/ml.The patient sample was diluted with increasing amounts of negative serum, as the result was lower than the level of detection (lod): the repeat result at 1:2 dilution was 0.588 ng/ml.The repeat result at 1:4 dilution was 0.311 ng/ml.The repeat result at 1:8 dilution was 0.156 ng/ml.The initial results were not reported outside the laboratory, as they did not match the patient's clinical diagnosis.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation confirmed the customer's elecsys total psa (total psa) and elecsys free psa assay results.The investigation tested the patient sample for interferents using dilution tests, heterophil antibody testing (hbt), spiking treatment, and rf ii tests.The dilution and spiking treatment tests detected the tpsa auto-antibody or tpsa isoform against total psa in the patient sample; no interferent was detected in the heterophil antibody testing (hbt) and rf ii tests.Elecsys total psa (total psa) product labeling states, "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.It is known that in rare cases, psa isoforms do exist that may be measured differently by different psa tests.Findings of this kind have occasionally been reported for psa tests from various manufacturers.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." elecsys free psa product labeling states, "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation determined that an interferent and rare isoform had caused the event.The investigation did not identify a product problem.

• 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: 22026606
• Report Number: 1823260-2025-01499
• Device Sequence Number: 7266732
• Product Code: MTG
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000027
• 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): 06/13/2025

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: 07/31/2025
• Device Catalogue Number: 08828610190
• Device Lot Number: 785850
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/13/2025
• 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: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian