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

Catalog Number	09014977190
Medical Device Problem Codes	False Negative Result (1225); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 core unit is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys syphilis assay results from three samples from the same patient tested on the cobas 6000 core unit.Sample 1 on (b)(6)2024: the result from the analyzer was 0.092 (negative).The result from the enzyme-linked immunosorbent assay (elisa) assay was 12.515.Sample 2 on (b)(6) 2025: the result from the analyzer was 0.077 (negative).The result from the elisa assay was 10.189.Sample 3 on (b)(6) 2025: the result from the elisa assay was 11.619.The result from the analyzer was negative.The unit of measurement was not provided.The questionable result was not reported outside the laboratory as it did not match the patient's clinical diagnosis.
Additional Manufacturer Narrative
The qc recoveries were within range, but the specific dates were not provided.Two patient samples were received for investigation.The patient samples were tested with the elecsys syphilis immunoassay, investigational single treponemal antigen assay kits, and an alternative supplemental test.The investigation confirmed the customer's negative/non-reactive results.The investigation did not identify a product problem.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21275257
• Report Number: 1823260-2025-00288
• Device Sequence Number: 14405368
• 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): 04/30/2025

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: 09014977190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 04/30/2025
• 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