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

Catalog Number	08791732190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys total psa assay and elecsys free psa assay results from one patient sample tested on the cobas e 801 analytical unit.This medwatch is for the elecsys total psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for the elecsys free psa assay.The initial free psa result is 0.243 ng/ml.The initial total psa result is 0.0368 ng/ml.The repeat results were consistent with the initial results.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The patient sample was received for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
On (b)(6) 2026, the customer reported the elecsys total psa (total psa) assay and elecsys free psa assay repeat results for the reported patient sample: the repeat free psa result is 0.244 ng/ml.The repeat total psa result is 0.0412 ng/ml.
Additional Manufacturer Narrative
The results of the elecsys total psa (total psa) and elecsys free psa calibration are slightly lower, but within the specified ranges.The elecsys total psa (total psa) and elecsys free psa assay qc results are within the specified ranges.The investigation tested the patient sample for the elecsys total psa (total psa) and elecsys free psa assays; the customer's results were confirmed.The investigation tested the patient sample for interferents using a heterophilic blocking tube (hbt) treatment; poor recovery of total psa and normal recovery of free psa were detected.The investigation performed a striking experiment on the pretreated patient sample; a heterophilic antibody (igm) interferent against the elecsys total psa (total psa) assay was detected.The investigation determined that the heterophilic antibody (ha) igm against the elecsys total psa (total psa) assay in the patient sample caused the event.Product labeling states, "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.

• Brand Name: ELECSYS TOTAL 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: 24445677
• Report Number: 1823260-2026-00699
• Device Sequence Number: 10307872
• Product Code: MTF
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P990056/S039
• 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,Followup
• Report Date (Section B): 04/23/2026

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: 08/31/2026
• Device Catalogue Number: 08791732190
• Device Lot Number: 86528302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 04/01/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/31/2026; 04/23/2026
• 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