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	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e602 analyzer is (b)(6).Calibration and controls were acceptable.False reactive results may occur in elecsys syphilis, the assay has a specificity of < 100% per product labeling.Repeatedly reactive samples must be supplemented 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 elecsys syphilis assay performs within specification.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys syphilis on a cobas 8000 e 602 module.The patient sample resulted in a syphilis value of 3.42 coi (reactive) and it repeated as 3.70 coi (reactive).The sample was repeated again on (b)(6) 2025, resulting in a syphilis value of 2.93 coi (reactive).The patient was re-tested in other laboratories using competitor systems (abbott architect 2000i, alinity i syphilis tp, and charoite elisa analyzers).All competitor systems returned negative results.No specific results were provided.The customer noted they have had previous incidents of the same nature where elecsys syphilis results were positive and competitor results were negative.No specific information was provided.

• 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: 23869994
• Report Number: 1823260-2025-05299
• Device Sequence Number: 4552669
• Product Code: LIP
• UDI-Device Identifier: 07613336171950
• UDI-Public: 07613336171950
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 12/22/2025

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: 07/31/2026
• Device Model Number: SYPHILIS
• Device Catalogue Number: 09014977190
• Device Lot Number: 88097801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/22/2025
• 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 Age: 30 YR
• Patient Sex: Male