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

Model Number	SYPHILIS
Medical Device Problem Codes	False Negative Result (1225); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
1.There was an allegation of questionable false-negative elecsys syphilis results for one patient from the cobas 8000 core unit and for one patient from a cobas 6000 e601 module.2.Patient age range: 35 year 3.Patient weight range: asku 4.Patient sex breakdown: 1-male, 1-asku 5.Patient race breakdown: asku.6.Patient ethnicity breakdown: asku.
Additional Manufacturer Narrative
D4 expiration date: lot 73738801 is 31-aug-2024, lot 568606 is 30-sep-2022.For 1 event: 1.Summary of investigation results: the investigation determined that a general reagent issue can be excluded.Calibration and controls were acceptable.The investigation could not identify a product problem.The cause of the event could not be determined.2.Summary of follow-up/corrective actions taken: no follow-up actions taken.For 1 event: 1.Summary of investigation results: the investigation was unable to determine a specific root cause.The event was consistent with foam/air on the sample and/or on the reagent.The elecsys syphilis reagent performed within specification.2.Summary of follow-up/corrective actions taken: none.For both events: 3.Device returned to manufacturer? no.4.Device labeled for single use? no.5.Device reprocessed and reused? no.

• 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: 23066025
• Report Number: 1823260-2025-02931
• Device Sequence Number: 9671679
• Product Code: LIP
• UDI-Device Identifier: 07613336171950
• UDI-Public: 07613336171950
• Combination Product (Y/N): N
• PMA/510(K) Number: K211302
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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?: No
• Device Model Number: SYPHILIS
• Device Catalogue Number: 09014977190
• Device Lot Number: 73738801.568606
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown