MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS SYPHILIS; TREPONEMA PALLIDUM ASSAY

Catalog Number	09014977190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about questionable low results for a patient¿s sample tested with elecsys syphilis on a cobas 8000 core unit.The sample was initially tested and repeated on a cobas e602 analyzer, and the results were 0.344 coi and 0.346 coi (both results were interpreted as non-reactive).The sample was then repeated on a cobas e801 analyzer, and the 2nd repeat result was 0.454 coi (this result was interpreted as non-reactive).The non-reactive elecsys syphilis results did not match the patient's clinical diagnosis, and the sample was repeated.No questionable results were reported outside the laboratory.3rd repeat result: 3.41 s/co (interpreted as reactive when tested with wan200).4th repeat result: interpreted as reactive when tested with treponema pallidum particle agglutination (tppa) test.5th repeat result: interpreted as reactive when tested with toluidine red unheated serum test (trust) with a dilution factor of 1:2).
Additional Manufacturer Narrative
The cobas 8000 core unit serial number was (b)(6).The customer mentioned that the calibration and qc were acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
On 16-jun-2025, two aliquots (each 0.8 ml) from the same sample drawing were received for investigation and tested with: elecsys syphilis: the results were 0.410 coi (aliquot 1) and 0.418 coi (aliquot 2) and interpreted as non-reactive.Single antigen analysis: the result was non-reactive despite elevated ratios in igm modules (signal dynamics).Inno-lia blot(western blot): the result indicated weak reactivity and was interpreted as indeterminate.The patient sample was confirmed non-reactive with the elecsys syphilis assay.The evidence was provided by investigational single antigen analysis and inno-lia immunoblot testing that this sample might be derived from a patient in a very early (pre-)seroconversion phase.A follow-up blood draw at a later time point is recommended to confirm further progression/completion of seroconversion and to confirm the positive serological status of the patient.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.

• Brand Name: ELECSYS SYPHILIS
• Common Device Name: TREPONEMA PALLIDUM ASSAY
• 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: 22148855
• Report Number: 1823260-2025-01728
• Device Sequence Number: 15416217
• Product Code: LIP
• UDI-Device Identifier: 07613336171950
• UDI-Public: 07613336171950
• 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): 08/22/2025

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: 07/31/2025
• Device Catalogue Number: 09014977190
• Device Lot Number: 803333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/22/2025
• 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 Age: 30 YR
• Patient Sex: Male