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	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with elecsys syphilis on a cobas e 801 analytical unit.The patient sample resulted in syphilis values of 5.26 coi (reactive), 5.28 coi (reactive), and 5.27 coi (reactive).The patient received an rpr test and this was found to be non-reactive.The complained patient sample was tested with a fluorescent treponemal antibody test at an outside laboratory and the result was non-reactive.Based on the patient's clinical presentation, they did not receive treatment.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and controls were acceptable.There was no indication of a reagent performance issue.A review of alarm trace data showed sample clot detection, sample short, and abnormal aspiration alarms around the time of the event.These are indicators of poor sample quality.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.All initially reactive samples should be redetermined in duplicate with the elecsys syphilis assay.If cutoff index values <1.00 are found in both cases, the samples are considered negative for anit-tp antibodies.Initially reactive samples giving cutoff index values of = 1.00 in either of the retests are considered repeatedly reactive.Repeatedly reactive samples must be supplemented according to recommended confirmatory algorithms.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: 24777710
• Report Number: 1823260-2026-01237
• Device Sequence Number: 17675851
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/22/2026
• 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 Sex: Female