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	05/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The last calibration was performed on (b)(6) 2026.Per product labeling, "renewed calibration is recommended after 12 weeks when using the same reagent lot." the provided qc was passing within the specified ranges.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable reactive elecsys syphilis result from the cobas e 801 analytical unit for 1 patient.The initial result was 1.2 coi (reactive).The sample was retested using the autobio platform and treponema pallidum particle agglutination (tppa), and both results were negative.The result of 1.2 coi was reported, and the doctor ordered a repeat blood draw out of caution of treating the patient with penicillin.On (b)(6) 2026, with a new sample, the result was 0.4 coi (non-reactive).To investigate the discrepancy, the customer re-centrifuged the refrigerated sample #1 and re-tested it; the result was 9.88 coi (reactive).On (b)(6) 2026, both samples were re-centrifuged and re-tested: sample #1's result was 10.0 coi (reactive), and sample #2's result was 1.4 coi (reactive).On (b)(6) 2026, the centrifuged serum from both samples was cross-tested on the abbott platform, and both yielded negative results.

• 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: 25359679
• Report Number: 1823260-2026-02165
• Device Sequence Number: 9985208
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 09/21/2026

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: 88102301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 09/21/2026
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female