MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS SYPHILIS; TREPONEMA PALLIDUM ASSAY

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	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys syphilis assay results for two samples from the same patient tested on the cobas e 411 analyzer (rack system).Sample 1: the result was 1.63 coi (reactive).Sample 2: the result was 1.37 coi (reactive).It was reported that the sample dilution did not resolve the reactivity, and the test results remained reactive.Additionally, the patient sample was tested on the abbott system, where a reactive result was obtained.A confirmatory test was performed and the result was negative.
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).Please note that false reactive results may occur in elecsys syphilis as the specificity is less than 100%.Per the product labeling, "all initially reactive samples should be redetermined in duplicate with the elecsys syphilis assay.If cutoff index values < 1.00 are found in both cases, the samples are considered negative for anti-tp antibodies.Initially reactive samples giving cutoff index values of = 1.00 in either of the redeterminations are considered repeatedly reactive.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 elecsys syphilis assay performs within specification.

• Brand Name: ELECSYS SYPHILIS
• Common Device Name: TREPONEMA PALLIDUM ASSAY
• 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: 25135305
• Report Number: 1823260-2026-01833
• Device Sequence Number: 15797284
• Product Code: LIP
• UDI-Device Identifier: 07613336171950
• UDI-Public: 07613336171950
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 05/11/2026

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: 09014977190
• Device Lot Number: 863863
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/11/2026
• 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