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

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	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys syphilis results for 1 patient sample on a cobas e 801 analytical unit compared to two competitor assays.The patient had an elecsys syphilis result of 0.259 coi (non-reactive), an abbott syphilis result of 0.53 s/co (non-reactive), and an autobio syphilis result of 9.984 (reactive).The units of measurement for the autobio result were not provided.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer confirmed that the autobio result was a false reactive result and that the elecsys syphilis was correctly negative.The elecsys syphilis assay performs within specification.The investigation did not identify a product problem.

• 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: 25204420
• Report Number: 1823260-2026-01946
• Device Sequence Number: 15961410
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• 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): N
• 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): 05/18/2026

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: 07/31/2026
• Device Model Number: SYPHILIS
• Device Catalogue Number: 09015051190
• Device Lot Number: 88102301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/18/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATORVASTATIN CALCIUM.; BETAHISTINE MESILATE.; CLOPIDOGREL BISULFATE.
• Patient Age: 79 YR
• Patient Sex: Female