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 Codes	Localized Skin Lesion (4542); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 lot no continued: 56860601,669299,48170501,592016,53442101,481713, 682565.D4 expiration date: lot 46594400 is 30-apr-2021, lot 76052401 is 31-dec-2024, lot 705727 is 29-feb-2024, lot 76052401 is 31-dec-2024, lot is asku, lot 568606 is asku, lot 669299 is 30-nov-2023, lot 48170501 is 30-jun-2021, lot 592016 is 31-dec-2022, lot 53442101 is 31-mar-2022, lot 481713 is 30-jun-2021, lot 682565 is 31-dec-2023.For 1 event: 1.Summary of investigation results: the investigation determined that the assay performed within specifications, as calibration and controls were acceptable.2.Summary of follow-up/corrective actions taken: no follow-up actions taken.A sample from the patient was unavailable for investigation.For 1 event: 1.Summary of investigation results: the investigation determined that the assay performs within specifications.Calibration and controls were acceptable.The issue is related to a sample-specific discrepancy.2.Summary of follow-up/corrective actions taken: no follow-up actions taken.For 1 event: 1.Summary of investigation results: as no sample material could be provided, the investigation was unable to determine a root cause.The elecsys syphilis reagent performed within specification.2.Summary of follow-up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: a sample from the patient was submitted for investigation, and the customer¿s negative result was confirmed.The elecsys syphilis assay was found to perform within specification.2.Summary of follow-up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: as no sample material could be provided, the investigation was unable to determine a root cause.The elecsys syphilis reagent performed within specification.For 1 event: 1.Summary of investigation results: sample material from the patient was received for investigation and the customer¿s results were confirmed.The elecsys syphilis reagent performs within specification.2.Summary of follow-up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: sample material from the patient was received for investigation.The investigation determined that the event was due to a sample-specific issue.2.Summary of follow-up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: as no sample material could be provided, the investigation was unable to determine a root cause.The elecsys syphilis reagent performed within specification.2.Summary of follow-up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: the investigation determined that the assay performs within specifications.A patient sample-specific discrepancy is likely.2.Summary of follow-up/corrective actions taken: no follow-up actions taken.A sample from the patient was unavailable for investigation.For 1 event: 1.Summary of investigation results: the investigation determined that the discrepancy was due to the very early stage of the patient¿s syphilis infection(pre-seroconversion).The elecsys syphilis assay result was slightly increased in the first and second measurements, but was still below the cut-off value (1.0 coi).Per product labeling: 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 reagent performed within specification.2.Summary of follow-up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: as no sample material could be provided, the investigation was unable to determine a root cause.The elecsys syphilis reagent performed within specification.2.Summary of follow-up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: sample material from the patient was received for investigation, and the customer¿s results were confirmed.The elecsys syphilis reagent performed within specification.2.Summary of follow-up/corrective actions taken: none.For all 12 events: 3.Device returned to manufacturer? no.4.Device labeled "for single use?" no.5.Device reprocessed and reused? no.
Event or Problem Description
1.Describe the event: the initial reporter complained of discrepant results for elecsys syphilis: 1 patient-cobas 8000 e 602 module and a cobas e 411 analyzer.2 patient -cobas 8000 e 801 module.3 patient-cobas e 801 analytical unit.3 patient-cobas 8000 core unit.2 patient-cobas 8000 - cobas e 602 module.1 patient-cobas 6000 core unit.2.Patient age range: 18 month-75 years.3.Patient weight range: asku.4.Patient sex breakdown: 2-female.4-male.6-asku.5.Patient race breakdown: 1-asian.11-asku.6.Patient ethnicity breakdown: 1-non-hispanic/latino.11-asku.

• 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: 23065297
• Report Number: 1823260-2025-02927
• Device Sequence Number: 9680996
• Product Code: LIP
• UDI-Device Identifier: 04015630934881
• UDI-Public: 04015630934881
• Combination Product (Y/N): N
• PMA/510(K) Number: K160910
• Exemption Number: VMSR
• Number of Events Summarized: 12
• 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: 06923348190
• Device Lot Number: 46594400,76052401,705727,
• 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