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	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about questionable low results for 2 samples from the same patient tested with elecsys syphilis assay on a cobas e 801 analytical unit.Sample 1 was tested in a different laboratory, and the result was positive.Sample 1 was then repeated with elecsys syphilis at the customer's site, resulting in a negative value.The dates of testing were not provided, and therefore, the specific date of event is unknown.Sample 2 was tested on (b)(6) 2025, resulting in an initial elecsys syphilis result of 0.0709 coi (interpreted as non-reactive).Sample 2 was repeated on (b)(6) 2025, resulting in the following: 1st repeat result: 1.55 index (tested on abbott syphilis tp and interpreted as positive).2nd repeat result: negative (tested on syphilis vdrl).Immuno blot igg result: only the specific protein of tpn15 was present and was interpreted as indeterminate.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The calibration was last performed on 27-jun-2025 and was within the expected ranges.Qc was within the range.The sample was received for investigation on 11-aug-2025.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation of the received sample resulted in the following: elecsys syphilis: 0.075 coi (interpreted as non-reactive).Tpla: 0 tu (accompanied by a data flag and interpreted as non-reactive).Single antigen analysis: non-reactive.Rpr2: 0 ru (accompanied by a data flag and interpreted as non-reactive).Inno-lia blot syphilis: only tpn15 reactivity (interpreted as indeterminate).Fta abs-igm: <1:10 (interpreted as non-reactive).Fta abs-igg: <1:10 (interpreted as non-reactive).Diasorin liaison treponema screen: <0.1 index (interpreted as non-reactive).The non-reactive elecsys syphilis result was confirmed.The sample was considered non-reactive for anti-treponemal antibodies, and therefore, the elecsys syphilis result is considered correct.The positive result reported by the customer could be explained by non-specific reactivity to (recombinant) tpn15 in the product labeling used, leading to a false reactive result.The investigation did not identify a product problem.The non-reactive elecsys syphilis result was confirmed to be correct.

• 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: 22819312
• Report Number: 1823260-2025-02524
• Device Sequence Number: 5738650
• Product Code: LIP
• UDI-Device Identifier: 04015630940356
• UDI-Public: 04015630940356
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/05/2025

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: 11/30/2025
• Device Catalogue Number: 07251378190
• Device Lot Number: 828502
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 11/05/2025
• 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
• Patient Age: 29 YR
• Patient Sex: Female