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); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys free psa result from the cobas e 402 analytical unit.This medwatch will apply to the elecsys free psa assay.Please refer to the medwatch with a1 patient indentifier (b)(6) for the information related to the elecsys total psa assay.The initial free psa result was 0.275 ng/ml, and a total psa from a cobas e 411 with a result of 0.063 ng/ml.The sample was sent to another lab and ran on another cobas e 411 analyzer with the same results of free psa greater than total psa.The customer then ran the sample on an abbott platform, and the free psa result was 0.04 ng/ml, and the total psa result was 0.08 ng/ml.
Additional Manufacturer Narrative
The cobas e 402 analytical unit serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The qc data that was provided did not include timestamps, so it is unclear if the qc was within range on the day the sample was measured.The calibration data provided for the cobas e411 was inconclusive.A sample was received for investigation.In the investigation, the results generated on both instruments are very similar to the results generated at the customer site.The investigation determined that the root cause is the presence of interfering stubstance or substances in the elecsys total psa assay.No product issue was found as the confirmed and possible interferences are disclaimed in the method sheet for this assay.Per the product labeling for the assay, "it is known that in rare cases psa isoforms do exist which may be measured differently by different psa tests.Findings of this kind have occasionally been reported for psa tests from various manufacturers.11,12,13 for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other finding.".

• 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: 22202252
• Report Number: 1823260-2025-01826
• Device Sequence Number: 6764582
• Product Code: MTG
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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): 09/05/2025

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: 05/23/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 09/05/2025
• 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: ACURIL 5MG; AMARYL 2MG; ASPICOT 100MG; CONCOR 5MG; DIURESAL 40MG; GLUCOPHAGE 850MG; GLYXAMBI 10MG/5MG; SINLIP 10MG; TRAJENTA 5MG; TROKEN 75MG
• Patient Age: 68 YR
• Patient Sex: Male