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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
There was an allegation of questionable false negative elecsys syphilis results for apheresis platelet donation from one patient.The customer used a cobas e801 analyzer.On (b)(6) 2025, the result was reported to be 0.159 coi (non-reactive).The result using the abbott architect was reported to be 0.15 s/co.No interpretation was provided.On (b)(6) 2025, the result was reported to be 0.772 coi (non-reactive).The result using the abbott architect was reported to be 3.64 s/co.No interpretation was provided.On (b)(6) 2025, the result was reported to be 2.19 coi (reactive).The result using the abbott architect was reported to be 6.87 s/co.No interpretation was provided.On (b)(6) 2025, the result was reported to be 14.8 coi (reactive).The result using the abbott architect was reported to be 12.02 s/co.No interpretation was provided.Allegedly, at the time of the reactive result on (b)(6) 2025, the two platelet donations had already been transfused into two patients on (b)(6) 2025.An initial blood test of the recipients reportedly showed no evidence of a syphilis infection.Reportedly, a second testing of the recipients is planned in approximately eight weeks.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
The analyzer serial number was not provided.Sample material from the donor samples was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch field b7 other relevant history was updated with additional information.Two samples from the donor were sent for further investigation.The first sample was found to be non-reactive in the elecsys syphilis assay.Evidence was provided that this sample is from a very early (pre)seroconversion phase.For the second sample, the reactive result in the elecsys syphilis was confirmed as there was no discrepancy with other methods, and additional testing provided further evidence for a seroconversion / active, early syphilis in this donor.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.
Additional Manufacturer Narrative
Additional information was received that the second testing of the two platelet donation recipients, performed eight weeks later, had results showing no evidence of a syphilis infection.No specific data was provided.Therefore, there was no serious incident as a result of the roche assay.

• 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: 22479258
• Report Number: 1823260-2025-02122
• Device Sequence Number: 8015922
• 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,Followup
• Report Date (Section B): 10/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 10/08/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/29/2025; 10/23/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown