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

Model Number	SYPHILIS
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 411 analyzer (rack system) serial number is (b)(6).The investigation included a review of the data set provided by the customer: the 08-oct-2025 calibration results were within the specified ranges.The customer did not perform qc on the date of event.The (b)(6) 2025 qc level 2 result was out of range.The 14-oct-2025 qc results were within the specified ranges.The investigation determined the event was consistent with a sample-specific discrepancy.False reactive results may occur in elecsys syphilis, as the specificity claim is less than 100%.Product labeling states: "elecsys syphilis overall spe­cificity - 99.88%" "interpretation of the results all initially reactive samples should be retested in duplicate with the elecsys syphilis assay.If cutoff index values < 1.00 are found in both cases, the samples are considered negative for anti-treponema pallidum antibodies.Initially reactive samples giving cutoff index values of = 1.00 in either retests are considered repeatedly reactive.Repeatedly reactive samples must be supplemented according to recommended confirmatory algorithms."calibration calibration frequency: calibration must be performed once per reagent lot using syphilis cal1, syphilis cal2 and fresh reagent (i.E.Not more than 24 hours since the reagent kit was registered on the analyzer).Calibration interval may be extended based on acceptable verification of calibration by the laboratory.Renewed calibration is recommended as follows: every 28 days when using the same reagent lot every 7 days when using the same cobas e pack on the analyzer as required: e.G.Quality control findings with precicontrol syphilis outside the defined limits." "quality control use precicontrol syphilis or other suitable controls for routine quality control procedures.Controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit, and following each calibration.The control intervals and limits should be adapted to each laboratory¿s individual requirements.Values obtained should fall within the defined limits.Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.If necessary, repeat the measurement of the samples concerned.Follow the applicable government regulations and local guidelines for quality control." for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The elecsys syphilis assay performs within specification.
Event or Problem Description
There was an allegation of questionable positive elecsys syphilis results from the cobas e 411 analyzer (rack system).The initial result was 1.11 cut-off index coi (reactive).The first repeat result was 1.07 coi (reactive).The second repeat result was 1.26 coi (reactive).The "non-treponemal result" was negative.The enzyme-linked immunosorbent (elisa) assay result was negative.

• 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: 23456679
• Report Number: 1823260-2025-04469
• Device Sequence Number: 8056782
• Product Code: LIP
• UDI-Device Identifier: 07613336171950
• UDI-Public: 07613336171950
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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
• Report Date (Section B): 11/03/2025

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): Initial
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/03/2025
• 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: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White