MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS SYPHILIS; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Model Number	SYPHILIS
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant results with multiple assays for two samples from the same patient tested on a cobas e 801 analytical unit.Elecsys hbsag ii: 438 coi elecsys hbsag ii quant ii: 12.40 iu/ml (detectable) elecsys syphilis: 12.6 coi elecsys hiv duo: 96.3 coi hiv immunoblotting result: negative syphilis confirmation (vdrl and tpha): negative the patient¿s general practitioner requested a repeat run.On (b)(6) 2025, a new sample was run, and the results were nearly identical to the initial test.The screening tests showed high coi values, while all confirmatory tests and pcr results were negative.This medwatch will cover elecsys syphilis.Refer to medwatch with a1 patient identifier (b)(6) for information on the elecsys hbsag ii results, and medwatch with a1 patient identifier (b)(6) for information on the elecsys hiv duo results.
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
It was communicated that the patient was previously tested for hepatitis c virus using the e801 assay, which yielded a negative result.
Additional Manufacturer Narrative
Per the product labeling, "redetermine initially reactive samples in duplicate with the elecsys syphilis assay.Repeatedly reactive samples must be confirmed according to recommended confirmatory algorithms.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.The issue is determined to be sample-specific.

• Brand Name: ELECSYS SYPHILIS
• Common Device Name: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• 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: 23606847
• Report Number: 1823260-2025-04751
• Device Sequence Number: 9917731
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K211302
• 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): 01/12/2026

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 Model Number: SYPHILIS
• Device Catalogue Number: 09015051190
• Device Lot Number: 86355301
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 12/22/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/11/2025; 01/12/2026
• 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: Male