MAUDE Adverse Event Report: ROCHE DIAGNOSTICS SYPHILIS ELECSYS E2G; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Model Number SYPHILIS E2G

Device Problem False Negative Result (1225)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2022

Event Type  malfunction  

Manufacturer Narrative

All of the calibration signals were within the expected ranges.The investigation is ongoing.

Event Description

There was an allegation of questionable syphilis elecsys e2g results for 1 patient on a cobas 8000 core unit, serial number (b)(4).The patient's sample produced 2 negative results (0.914 coi and 0.951 coi) on two different cobas e801 modules.The interpretation of this assay is < 1.0 negative; = 1.0 positive.The cobas e801 module serial numbers are (b)(4).A different sample from the patient was tested at another clinic and it produced a positive syphilis result.The numerical result was not provided.No further information was provided regarding this result.The original patient sample was then tested on a different c8000 line and produced another negative result (0.913 coi).Confirmatory testing with a treponema pallidum haemagglutination (tpha) kit was performed with the original sample and a "strong positive result (4+)" was obtained.The results were reported outside of the laboratory.

Manufacturer Narrative

The patient also received a negative test result using a non-treponemal test (rpr).The patient was doing a self test kit as part of a general sexual health check.There was no allegation of a medical adverse event due to the reported discrepant elecsys syphilis results.There was no allegation of spread of infectious disease due to the reported discrepant elecsys syphilis results.The customer's qc results were acceptable.The investigation reviewed the system's alarm trace and no abnormalities for the alleged sample were found.The patient's sample was requested for investigation.However, the sample could not be investigated based on the limited remaining volume of the sample.A negative test result does not completely rule out the possibility of an infection with treponema pallidum.Serum or plasma samples from the very early (pre-seroconversion) phase or the late phase of a syphilis infection can occasionally yield negative findings.Based on the data provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: SYPHILIS ELECSYS E2G
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13568452
• MDR Text Key: 292582711
• Report Number: 1823260-2022-00457
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

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: 06/30/2022
• Device Model Number: SYPHILIS E2G
• Device Catalogue Number: 09015051190
• Device Lot Number: 550540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/21/2022
• Supplement Dates Manufacturer Received: 02/22/2022
• Supplement Dates FDA Received: 03/16/2022
• 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