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

Model Number	SYPHILIS
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The syphilis reagent expiration date was not provided.The e601 module serial number was (b)(6).The qc was within range.The customer considered the reactive elecsys syphilis result to be correct.The product labeling states: "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 specifications.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys syphilis assay on a cobas 6000 e601 module.Initial result: 11.74 coi.1st repeat result: 11.26 coi (tested after centrifugation).The sample was repeated on a 3rd party platform, resulting in the following: 2nd repeat result: 0.276 (interpreted as negative).3rd repeat result: 0.297 (interpreted as negative).4th repeat result: 0.252 (interpreted as negative).The sample was repeated using a rapid test strip, and the 5th repeat result was positive.No questionable results were reported outside the laboratory.

• 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: 23730353
• Report Number: 1823260-2025-04969
• Device Sequence Number: 15888545
• 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): 12/05/2025

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 Model Number: SYPHILIS
• Device Catalogue Number: 09014977190
• Device Lot Number: 855502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/05/2025
• 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