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

Catalog Number	09015051190
Medical Device Problem Codes	False Negative Result (1225); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about questionable low results for 1 patient sample tested with elecsys syphilis assay on a cobas e801 module when compared to 2 different laboratories.On (b)(6) 2024: the sample was initially tested in another laboratory and the result was reactive.On (b)(6) 2024: the sample was re-tested at the customer's site and the result was 0.0732 coi and considered non-reactive.No questionable result was reported outside the laboratory as the customer questioned the result.On (b)(6) 2024: the sample was repeated in another hospital and the result was reactive.
Additional Manufacturer Narrative
The syphilis reagent expiration date was not provided.The e801 module serial number was (b)(6).The customer requested for the sample to be investigated.The calibration was last performed on (b)(6) 2024 and it was within expected ranges.The qc was within range on the day of the event.The provided data showed that the gear pump head was due for replacement.The investigation is ongoing.
Additional Manufacturer Narrative
One sample was received for investigation on 24-jan-2025.The investigation results were: elecsys syphilis: 0.0841 coi (considered as non-reactive).Tpla: 0 tu (accompanied by a data flag and considered as non-reactive).Single antigen analysis: non-reactive.Inno-lia blot: indeterminate.Rpr2: 0 ru (accompanied by a data flag and considered as non-reactive).The non-reactive result was confirmed by testing with the elecsys syphilis immunoassay.In addition, the non-reactive result was further confirmed by supplemental testing with an additional treponemal assay (tpla2) and a non-treponemal assay (rpr2), as well as by investigational single antigen analysis.The result of the inno-lia confirmation assay was indeterminate.The investigation did not identify a product problem.The investigation did not show confirmed serological evidence for a recent, active, treated and/or past syphilis infection.The sample is considered to be negative for antibodies to treponema pallidum.

• 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: 21020709
• Report Number: 1823260-2024-03829
• Device Sequence Number: 19825826
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 03/26/2025

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: 09015051190
• Device Lot Number: 801831
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 03/26/2025
• 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