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

Model Number	SYPHILIS
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a discrepant result with the elecsys syphilis for one patient sample on a cobas e 602 module.The following results were provided: elecsys syphilis result: 0.097 coi, non-reactive.Enzyme-linked immunoassay (elisa) result: 24.456 s/co, reactive.Treponema pallidum particle agglutination (tppa) test result: reactive.Electrochemiluminescence (eclia/clia) test results: non-reactive.Western blot: non-reactive.No erroneous result was released outside of the laboratory.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The elecsys syphilis non-reactive result was confirmed by another platform in clia, which was deemed correct by the customer.The investigation did not identify a product problem.

• 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: 23076153
• Report Number: 1823260-2025-03049
• Device Sequence Number: 15951670
• Product Code: LIP
• UDI-Device Identifier: 07613336171950
• UDI-Public: 07613336171950
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/17/2025

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: 11/30/2025
• Device Model Number: SYPHILIS
• Device Catalogue Number: 09014977190
• Device Lot Number: 82846801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 09/17/2025
• 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 Sex: Unknown