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

Model Number SYPHILIS

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Event 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).

Manufacturer Narrative

Sample material was requested for investigation.

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
• Type of Device: 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
• MDR Text Key: 305522039
• Report Number: 1823260-2022-02669
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 04015630934881
• UDI-Public: 04015630934881
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K160910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Male