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	12/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).Sample material from two donations was requested for investigation.
Event or Problem Description
There was an allegation of a questionable false negative elecsys syphilis result for one patient sample tested on a cobas e 801 analyzer.Based on a retrospective data analysis, a donor sample that had previously consistently tested positive was found negative.The following results were provided: donation from (b)(6) 2024: the initial elecsys syphilis result was 0.867 coi (negative).The repeat elecsys syphilis result of a retention sample after (b)(6) 2025 was 1.32 coi and 1.32 coi (repeatedly positive).The immunoblot analysis (fujirebio) was positive.Donation from 30-may-2025: the elecsys syphilis result was 1.33 coi, 1.40 coi, and 1.30 coi (repeatedly positive).The immunoblot analysis (fujirebio) was indeterminate.The repeat immunoblot analysis (fujirebio) was positive using another aliquot of the same sample donation that was provided on (b)(6) 2025.Allegedly, the syphilis diagnosis and its timing were not known to the customer.Reportedly, the donor has been regularly testing positive with the syphilis elecsys test since (b)(6) 2020, and the result of the confirmatory diagnostics was negative.Thus, the donor was approved for further donations.
Additional Manufacturer Narrative
The investigation was based on the dataset provided by the customer as well as internal testing of customer returned material.Qc and calibration data were found to be within the specified ranges.Sample material from two donations was used for internal testing.Both samples were found to be reactive with the elecsys syphilis assay.The customer¿s non-reactive result for the sample donation from (b)(6) 2024 was not reproducible.Supplemental testing with other treponemal (tpla2, inno-lia) and non-treponemal (rpr2) methods provided evidence for a true (igg) reactivity in both samples, indicating a past/previous syphilis infection.The donor likely contains low titers of (igg) antibodies, as either elevated indices (alinity i, diasorin liaison) or low (reactive) titers/ indices near the cutoff (fta-abs igg, elecsys, inno-lia, rpr2) were reported for both treponemal and non-treponemal assays of different formats.Notably, the customer reported a relatively high value for calibrator 2 in the calibration with elecsys syphilis lot 783548 that was used for the measurement on (b)(6) 2024.Internal data for lot 783548 and recent repeat measurements with the same lot yielded much lower calibrator 2 signals.It should be considered that an erroneous calibration, resulting in increased calibrator 2 signals, caused the initial discrepant non-reactive result for the sample from (b)(6) 2024.This is further supported by the fact that the recovery of this sample with lot 783548 (0.867 coi on (b)(6) 2024) was only 65% compared to internal repeat measurements (1.33 coi on (b)(6) 2025) using the same lot.Based on the totality of the investigation performed, no product problem was identified.

• 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: 22703558
• Report Number: 1823260-2025-02386
• Device Sequence Number: 15673128
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 09015051190
• Device Lot Number: 78354801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/04/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown