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

Model Number SYPHILIS

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation stated since the sample could not be provided, the investigation could not be completed.The investigation did not identify a product problem.The cause of the event could not be determined.Assays from different manufacturers can generate different results due to the different antigens used for different treponemal tests.The follow up/corrective action for this event was that the sample was requested for investigation but could not be provided.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.Low results were generated by the cobas 8000 e 602 module for elecsys syphilis.The event involved a total of 1 patient.There patient is male.

• Brand Name: ELECSYS SYPHILIS
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofferstrasse 116; na; mannheim (baden-wurttemberg), na 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8549725
• MDR Text Key: 143417160
• Report Number: 1823260-2019-90130
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 04015630934881
• UDI-Public: 04015630934881
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

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?: No
• Device Operator: No Information
• Device Model Number: SYPHILIS
• Device Lot Number: 33880200
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Type of Device Usage: N
• Patient Sequence Number: 1