MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS SYPHILIS; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Catalog Number	07251378190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for three samples from the same patient tested with elecsys syphilis on a cobas e 801 analytical unit.Negative values were obtained on the e 801 analyzer, but competitor systems showed positive values.No units of measure were provided for the competitor results.The first sample resulted in syphilis values of 0.53 coi (non-reactive) and 0.471 coi (non-reactive) when tested on the e801 analyzer.The sample was repeated using the liaison method, resulting in a value of 6.53.The sample was repeated using the tpha fortress method, resulting in an "equivocal" value.The sample was repeated using the rpr aix method, resulting in a value of 1:4.The second sample resulted in a syphilis value of 0.688 (non-reactive) when tested on the e801 analyzer on (b)(6) 2025.The sample was repeated using the liaison method, resulting in a value of 10.3.The sample was repeated using the tpha fortress method, resulting in a "detected" value.The third sample resulted in syphilis values of 0.61 coi (non-reactive) and 0.615 (non-reactive) when tested on the e801 analyzer on (b)(6) 2025.The sample was repeated using the liaison method, resulting in a value of 4.02.The sample was repeated using the tpha fortress method, resulting in a "detected" value.The sample was repeated using the rpr aix method, resulting in a value of 1:2.
Additional Manufacturer Narrative
The serial number of the e801 analyzer is (b)(6).The patient's samples were requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Section b7 was updated.1st sample: liaison syphilis result of 6.53 was considered reactive.Rpr aix result of 1:4 was considered reactive.2nd sample: liaison syphilis result of 10.3 was considered reactive.3rd sample: liaison syphilis result of 4.02 was considered reactive.Rpr aix result of 1:2 was considered reactive.The investigation is ongoing.
Additional Manufacturer Narrative
No sample material was available for investigation.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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21918244
• Report Number: 1823260-2025-01304
• Device Sequence Number: 9031758
• Product Code: LIP
• UDI-Device Identifier: 04015630940356
• UDI-Public: 04015630940356
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160910
• 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,Followup
• Report Date (Section B): 07/30/2025

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 Catalogue Number: 07251378190
• Device Lot Number: ASKU
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 07/28/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/11/2025; 07/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BENZYLPENICILLIN; CEFTRIAXONE
• Patient Age: 32 YR
• Patient Sex: Male