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	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e601 analyzer is (b)(6).Calibration and controls were acceptable.The investigation is ongoing.Medwatch field e1.Initial reporter email address was provided (b)(6).
Event or Problem Description
The initial reporter stated they received a false negative result for one patient sample tested with elecsys syphilis on a cobas 6000 e601 module.No questionable results were reported outside of the laboratory.The values measured with the elecsys syphilis assay did not match the patient's clinical diagnosis.The patient sample resulted in a syphilis value of 0.133 coi (non-reactive).The sample was repeated and the result was still negative.Elisa testing performed on the patient sample resulted in a value of 18.67 (reactive with cutoff of 0.14).No units of measure were provided for the method.Immunochromatography test strips, tppa, and rpr testing performed on the patient were all positive.
Additional Manufacturer Narrative
A sample from the patient was provided for investigation.The results obtained by the customer could be reproduced.A single antigen analysis for igm and igg specific antibodies with an in-house test showed no reactivity.Fujirebio immunoblot innolia testing of the sample was negative with no visible bands.Based on the investigation, the patient sample is considered correctly non-reactive with the elecsys syphilis assay.The investigation did not identify a product issue.The product performs within specifications.

• 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: 19527817
• Report Number: 1823260-2024-01755
• Device Sequence Number: 18036163
• 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): 07/02/2024

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: 08/31/2024
• Device Catalogue Number: 06923348190
• Device Lot Number: 737361
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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: TERAZOSIN HYDROCHLORIDE TABLETS; VERAPAMIL HYDROCHLORIDE TABLETS
• Patient Age: 36 YR
• Patient Sex: Male