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	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).Calibration and qc were reportedly within specification.For hiv duo testing, all initially reactive samples (results = 1.0 coi) should be re-determined in duplicate with the elecsys hiv duo assay.Repeatedly reactive samples must be confirmed according to recommended confirmatory algorithms.Confirmatory tests include western blot and hiv rna tests.For syphilis testing, further clarification is needed by performing additional tests (e.G western blot, treponemal, and non-treponemal).For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.Based on the calibration and qc data, a general reagent issue could be excluded.No product problem was identified.
Event or Problem Description
There was an allegation of questionable elecsys hiv duo and elecsys syphilis results for 1 patient sample on a cobas e 801 analytical unit.This medwatch will cover syphilis.Refer to medwatch with a1 patient identifier (b)(6).For information on the hiv duo results.The hiv duo result was 1.61 coi, with the hiv antigen result being 1.61 coi and the anti-hiv result being 0.093 coi, and the syphilis result was 2.41 coi.Both results were interpreted as reactive.The sample was re-centrifuged and the results were consistent after retesting.The repeat results were not provided.The patient has no history hiv or syphilis infections and previously had non-reactive results at another hospital.

• 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: 24520829
• Report Number: 1823260-2026-00786
• Device Sequence Number: 21246625
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: 881023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/05/2026
• 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: 13 YR
• Patient Sex: Unknown
• Patient Race: Asian