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

Catalog Number	06923348190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys syphilis results for 1 patient sample on a cobas 8000 e 602 module.The elecsys syphilis result was 0.863 coi (negative).The results using other methods were: positive with the tppa method, positive (4.69 unit of measure was not provided) with the wan200 (treponemal, chemical luminescence test) method, positive with the immunogold (treponemal) method, and negative with the trust method.The questionable result was not reported outside the laboratory.The sample was repeated due to the result not matching the patient's clinical diagnosis.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The calibration was acceptable.The customer used non-roche controls.The values were acceptable.The sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The sample was received for investigation.The investigation results were: the elecsys syphilis result was 1.07 cut-off index coi (reactive) and was verified by a duplicate confirmatory test.The investigation and the customer's results were close to the cut-off value.The single antigen analysis was reactive.The inno-lia fujirebio blot test was reactive.The alleged non-reactive elecsys result reported by the customer could not be reproduced.The sample is considered to be true positive for anti-treponemal antibodies.The cause of the event could not be determined.The assay performs within specification.

• 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: 20316093
• Report Number: 1823260-2024-02797
• Device Sequence Number: 8146992
• Product Code: LIP
• UDI-Device Identifier: 04015630934881
• UDI-Public: 04015630934881
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 10/18/2024

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: 12/31/2024
• Device Catalogue Number: 06923348190
• Device Lot Number: 76319501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TAMSULOSIN HYDROCHLORIDE SUSTAINED RELEASE CAPSULE
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Race: Asian