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

Model Number	SYPHILIS
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 lot no continued and d4 expiration date: lot 568606 is 30-sep-2022, lot 58447100 is 31-oct-2022, lot 71897301 is 31-may-2024, lot 73560301 is 31-jul-2024, lot 550530 is asku, lot 70572701 is 29-feb-2024, lot 801831 is asku, lot 413714-01 is 30-jun-2020, lot 801831 is 31-jul-2025, lot 64723800 is asku, lot 661502 is 31-oct-2023, lot 51677001 is 31-dec-2021, lot 42291401 is 31-jul-2020, 2-asku.For 5 events: 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: based on the data provided a clear root cause could not be identified.A general instrument or reagent problem could not be identified.The elecsys syphilis reagent performed within specification.2.Summary of follow up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: samples from both of patients were submitted for investigation.The results were consistent with early syphilis infections in both patients.The elecsys syphilis assay performed within specification.2.Summary of follow up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: two samples from the patient were received for investigation.The result for each sample was reactive.The customer¿s results were confirmed.The elecsys syphilis assay performed within specification.2.Summary of follow up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: samples from 40 donors were received for investigation.The results were consistent with single anti-tpn17 reactivity in the patients and a likely past syphilis infection now exhibiting low antibody titers.The elecsys syphilis assay performed within specification.2.Summary of follow up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: two samples from the patient were submitted for investigation and found non-reactive.A general product problem was not found.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 sample was repeatedly reactive using the elecsys syphilis assay.The elecsys syphilis assay performed within specification.2.Summary of follow up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: sample material from both patients was received for investigation.A general product problem was not found.Patient 1 was found non-reactive.Patient 2 was found reactive.It was suspected that the patient had an early syphilis infection.2.Summary of follow up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: due to the limited information and as no sample material could be provided, the investigation was unable to determine a root cause.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 assay performed within specification.2.Summary of follow up/corrective actions taken: none.For 1 event: 1.Summary of investigation results: based on the provided information, the elecsys syphilis reagent performs within specification.2.Summary of follow up/corrective actions taken: none.For all 15 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.There was an allegation of false-positive elecsys syphilis results: 5 patient- cobas 6000 e601 module.2 patient- cobas 8000 - cobas e 602 module.6 patient- cobas e 801 analytical unit.1 patient- cobas e 801 module.1 patient- unknown analyzer 2.Patient age range: 7 -55 years.3.Patient weight range: asku.4.Patient sex breakdown: 3-female, 5-male, 8-asku.5.Patient race breakdown: asku.6.Patient ethnicity breakdown: 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: 23066029
• Report Number: 1823260-2025-02928
• Device Sequence Number: 9671681
• 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: 15
• 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: 568606,58447100,71897301,
• 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