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

Model Number	SYPHILIS
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned negative results for 1 patient tested for elecsys syphilis (syphilis) on a cobas 6000 e 601 module.On (b)(6) 2021: the result from the e601 module was 0.580 coi (negative).The result from the intech treponema pallidum particle agglutination (tppa) method was "positive." the actual result was not provided.On (b)(6) 2022: the result from the e601 module was 0.790 coi (negative).The result from the intech tppa method was "positive." the actual result was not provided.Additional syphilis results were provided from 2 other methods: the result from the fujirebio tppa method was "positive." the actual result was not provided.The result from the trust method was "negative." the actual result was not provided.It is not clear if the results from the additional methods were from one of the samples from 2021 or 2022 or a different sample.Clarification has been requested but has not yet been received.The questionable roche results were reported outside of the laboratory.The e601 module serial number was (b)(4).
Additional Manufacturer Narrative
Sample material was requested for investigation.
Additional Manufacturer Narrative
No sample material was provided for investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15333824
• Report Number: 1823260-2022-02669
• Device Sequence Number: 20442837
• Product Code: LIP
• UDI-Device Identifier: 04015630934881
• UDI-Public: 04015630934881
• Combination Product (Y/N): N
• 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): 10/20/2022

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: 10/31/2022
• Device Model Number: SYPHILIS
• Device Catalogue Number: 06923348190
• Device Lot Number: 584471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 24 YR
• Patient Sex: Male