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

Catalog Number	09015051190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number was not provided.Sample material from the donor samples was requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable false-negative elecsys syphilis results for donor samples from a cobas e801 analyzer.The donor was providing platelet donations.On (b)(60 2025, the result was 0.118 coi (non-reactive).On (b)(6) 2025, the result was 0.409 coi (non-reactive).The result using the abbott architect was 2.63 s/co.No interpretation was provided.The repeat result using a cobas e602 analyzer with reagent lot 828482 was 0.382 coi (non-reactive).On (b)(6) 2025, the result was 10.5 coi (reactive).The result using the abbott architect was 12.37 s/co.No interpretation was provided.The repeat result using a cobas e602 analyzer with reagent lot 828482 was 7.53 coi (reactive).Additional information was provided that, using a different abbott analyzer and also diasorin liason, the syphilis results were found positive.No specific data was provided.Due to the limited information available, this event is being reported out of an abundance of caution.Refer to the medwatch with a1 patient identifier (b)(6) for additional samples involved in the event.
Additional Manufacturer Narrative
Medwatch field b7 other relevant history was updated with additional information.As no samples from this donor were available for investigation, no conclusions could be drawn.Serum or plasma samples from the very early (pre-seroconversion) phase or the late phase of a syphilis infection can occasionally yield negative findings.A general product problem was not found.

• 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: 22479264
• Report Number: 1823260-2025-02121
• Device Sequence Number: 15457827
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/29/2025

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 09015051190
• Device Lot Number: 814974
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/29/2025
• 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
• Patient Sex: Unknown