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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was(b)(6).The calibration was provided for (b)(6) 2025.Qc was within the ranges on the day of the event.Sample 1 and sample 2 were received for investigation on 15-oct-2025.The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable low results for 2 patients' samples tested with elecsys syphilis assay on a cobas e 801 analytical unit.Sample 1: initial result: 1.21 coi (interpreted as positive and tested on vitros ortho using chemiluminescent immunoassay clia laboratory method).1st repeat result: positive (tested with western blot).2nd repeat result: 0.731 coi (interpreted as negative and tested on cobas e 801).3rd repeat result: positive (tested on vitros after being frozen and thawed).Sample 2: initial result: 4.8 coi (interpreted as positive and tested on vitros ortho - clia laboratory method).1st repeat result: positive (tested with western blot).2nd repeat result: 0.979 coi (interpreted as negative and tested on cobas e 801).3rd repeat result: positive (tested on vitros after being frozen and thawed).No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
The investigation noted that samples 1 and 2 have exceeded the storage stability.During the investigation, both sample 1 and sample 2 yielded discrepant results across multiple syphilis screening and confirmation assays, preventing a definitive classification.While some initial tests and single antigen analysis indicated low-level treponemal reactivity, these findings were not consistently confirmed by supplemental treponemal and non-treponemal tests; analyte instability may be a contributing factor to the inconclusive results.The investigation determined the event was consistent with a patient sample issue.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.

• 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: 23335820
• Report Number: 1823260-2025-04252
• Device Sequence Number: 7808267
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 01/05/2026

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: 11/30/2025
• Device Model Number: SYPHILIS
• Device Catalogue Number: 09015051190
• Device Lot Number: 828502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 01/05/2026
• 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