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	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On e801 analyzer serial number (b)(6), the calibration was performed on (b)(6) 2025.The qc was performed with reagent lot number 828502 and was within the specified ranges.On e801 analyzer serial number (b)(6), the qc was performed with reagent lot number 828502 and was within the specified ranges.The samples were requested for investigation.The investigation is ongoing.Medwatch field e1 initial reporter establishment name - the full facility name was provided as (b)(6).
Event or Problem Description
We received an allegation about discrepant results for 2 patients tested with elecsys syphilis assay on cobas e 801 module analyzers.The customer allegedly started internally applying their own grey zone for the elecsys syphilis assay of 0.5 - 1.0 coi.Samples with results in this range are then reportedly re-analyzed using the abbott architect method.The customer alleged that approximately 15 patient samples per day fall within this grey zone range.Two samples (sample 1 and sample 2) were drawn from patient 1 and tested on e 801 analyzer serial number (b)(6).Sample 1 was tested and reportedly resulted in the following: initial result: 0.849 coi (tested with elecsys syphilis and interpreted as non-reactive).1st repeat result: 1.02 s/co (tested with abbott and interpreted as reactive).2nd repeat result: negative (tested with rapid plasma reagin (rpr) method).3rd repeat result: negative (tested with immuno blot method).Sample 2 was tested on (b)(6) 2025 and reportedly resulted in the following: initial result: 169 coi (tested with elecsys syphilis and interpreted as reactive).1st repeat result: 170 coi (tested with elecsys syphilis and interpreted as reactive).2nd repeat result: 171 coi (tested with elecsys syphilis and interpreted as reactive).3rd repeat result: 26.72 s/co (tested with abbott and interpreted as reactive).4th repeat result: positive (tested with rapid plasma reagin (rpr) method).5th repeat result: positive (tested with immuno blot method).On (b)(6) 2025, patient 2 was tested on e801 analyzer serial number (b)(6) and reportedly resulted in the following: initial result: 0.716 coi (tested with elecsys syphilis and interpreted as non-reactive).Repeat result: 1.72 s/co (tested with abbott and interpreted as reactive).For patient 1 and patient 2, all blood products derived from these donations were reportedly blocked.
Additional Manufacturer Narrative
The provided data showed that several calibration events were within the expected ranges.The samples were not provided for investigation.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." false results may occur in elecsy syphilis; sensitivity and specificity are less than 100%.The investigation did not identify a product problem.The elecsys syphilis assay performs within specifications.The cause of the event could not be determined.

• 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: 23303636
• Report Number: 1823260-2025-04201
• Device Sequence Number: 4863838
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: SYPHILIS
• Device Catalogue Number: 09015051190
• Device Lot Number: 82850201
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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