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

Catalog Number	08828610190
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure e 402 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 elecsys free psa (free psa) results from one patient sample tested on the cobas pure e 402 analytical unit.This medwatch is for the elecsys free 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 0.172 ng/ml.The repeat result from the cobas e 801 analyzer was 0.186 ng/ml.The repeat result from a referral laboratory using the chemiluminescent immunoassay (clia) laboratory method was 0.36 ng/ml.Free psa the initial result from the analyzer was 0.443 ng/ml.The repeat result from the cobas e 801 analyzer was 0.447 ng/ml.The repeat result from a referral laboratory using the clia laboratory method was 0.10 ng/ml.
Additional Manufacturer Narrative
The customer stated that the qc was acceptable.The investigation confirmed the customer's elecsys total psa (total psa) results.The patient sample was tested with an additional psa antibody of another specificity.The result showed a significant increase in psa at up to 0.447 ng/ml, indicating the presence of a rare psa isoform that cannot be completely detected by the standard elecsys total psa (total psa) assay.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: 22051696
• Report Number: 1823260-2025-01550
• Device Sequence Number: 8908828
• Product Code: MTG
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (Y/N): N
• 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): 06/23/2025

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: 78585001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/23/2025
• 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: 73 YR
• Patient Sex: Male