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	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.Medwatch field e1 initial reporter establishment name - the full facility name was provided as "(b)(6) hospital".
Event or Problem Description
The initial reporter stated they received questionable results for two samples collected from the same patient and tested with elecsys syphilis on a cobas 8000 e 801 module.The first sample collected from the patient resulted in a syphilis value of 32.6 coi (reactive).After re-centrifugation, the sample was repeated, resulting in a value of 31.0 coi (reactive).Tppa and trust results from this sample were negative.The sample was treated with a heterophilic antibody blocking tube and repeated twice on (b)(6) 2026, resulting in syphilis values of 30.8 coi (reactive) and 31.1 coi (reactive).A second sample collected from the patient resulted in a syphilis value of 31.0 coi (reactive) on (b)(6) 2026.
Additional Manufacturer Narrative
The patient's sample was provided for investigation.In-house investigations of the sample confirmed the reactive result in the elecsys syphilis assay.Additional investigational single-antigen analysis showed reactivity against anti-treponemal antibodies (tpn17).However, supplementary testing using the inno-lia syphilis score immunoblot yielded an indeterminate result.Therefore, the initial reactive result could not be fully confirmed by the available supplementary confirmatory testing methods.Single low anti-tpn 17 igg reactivity might be observed in patients exhibiting a past/prior syphilis infection (serological scar) that are only detectable by highly sensitive assays, as anti-tpn17 antibodies play an immunodominant role in the immune response.Alternatively, the result could potentially be due to an unspecific, unknown cross-reactivity.The investigation could not identify a product problem.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: 24234333
• Report Number: 1823260-2026-00344
• Device Sequence Number: 10188062
• 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): 03/30/2026

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: 03/31/2026
• Device Model Number: SYPHILIS
• Device Catalogue Number: 09015051190
• Device Lot Number: 85552301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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: 68 YR
• Patient Sex: Male
• Patient Race: Asian