MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS SYPHILIS; TREPONEMA PALLIDUM ASSAY

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	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 602 module serial number is (b)(6).The calibration was within the expected range prior to the event.It is not confirmed if the qc was passing prior to the event.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys syphilis results from the cobas e 602 module for two patients.Patient 1's initial result on (b)(6) 2025 was 4.67 coi (reactive).A second sample was collected on (b)(6) 2025 to test for treponema pallidum particle agglutination (tppa) and toluidine red unheated serum test (trust), both of which were negative.A third sample was collected on (b)(6) 2025, and the initial result was 0.86 coi (non-reactive), and the repeat result was 0.787 coi (non-reactive) patient 2's initial result on (b)(6) 2025 was 4.5 coi (reactive).A second sample was collected on (b)(6) 2025 to test for treponema pallidum particle agglutination (tppa) and toluidine red unheated serum test (trust), both of which were negative.The syphilis result was 0.474 coi (non-reactive).
Additional Manufacturer Narrative
Samples for both patients were received for investigation.The non-reactive results of patient a and b were reproduced as non-reactive with the elecsys syphilis assay and confirmed non-reactive using immunoblot testing.The investigation determined that the assay performed within specification, as false reactive results may occur with a specificity of less than 100%.Per labeling, "samples with a cutoff index = 1.00 are considered reactive in the elecsys syphilis assay.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.Reactive treponemal test results alone are not diagnostic of syphilis, treponemal test results should always be interpreted in conjunction with additional treponemal or nontreponemal serologic test results (as appropriate), medical history, clinical presentation and other findings, as recommended by the centers for disease control and prevention (cdc) sexually transmitted diseases treatment guidelines.".

• Brand Name: ELECSYS SYPHILIS
• Common Device Name: TREPONEMA PALLIDUM ASSAY
• 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: 23303384
• Report Number: 1823260-2025-04202
• Device Sequence Number: 9980299
• Product Code: LIP
• UDI-Device Identifier: 07613336171950
• UDI-Public: 07613336171950
• 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): 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): 12/05/2025

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: 03/31/2026
• Device Model Number: SYPHILIS
• Device Catalogue Number: 09014977190
• Device Lot Number: 855502
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/05/2025
• 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: PT1 - CRYOPRECIPITATE; PT1 - HUMAN ALBUMIN; PT1 - HUMAN IMMUNOGLOBULIN; PT1 - PLASMA; PT2 - HEPARIN
• Patient Age: 17 YR
• Patient Sex: Female