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)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys syphilis results from the cobas e 801 analytical unit.The initial result was 9.8 coi (positive).The repeat result was 9.96 coi (positive).The same sample was tested on another cobas e801 platform, and the result was positive (no specific result was provided).The sample was tested using other methods: antu a2000plus syphilis: 0.422 coi (negative).Antu a2000plus syphilis: 0.436 coi (negative).Iflash 3000h syphilis: 0.05 coi (negative).Tppa (negative).Trust (negative).
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The customer was not performing daily qc for the syphilis assay.Sample material from the patient was requested for further investigation.
Additional Manufacturer Narrative
Sample material from the patient was tested as part of the investigation.The positive result for the sample was confirmed.The tpn 17 igg and tpn 17 igm results were positive based on single antigen analyses.A western blot indicated weak reactivity for tpn 17 (+/-) that was interpreted as indeterminate.The investigaiton found that the event was due to a sample-specific discrepancy.Per product labeling, false reactive results may occur with the elecsys syphilis assay as the assay specificity is <100%.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 assay performed within specification.

• 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: 24223465
• Report Number: 1823260-2026-00329
• Device Sequence Number: 20889059
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• 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,Followup
• Report Date (Section B): 04/01/2026

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: 07/31/2026
• Device Model Number: SYPHILIS
• Device Catalogue Number: 09015051190
• Device Lot Number: 88102300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/01/2026
• 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 Age: 22 YR
• Patient Sex: Male