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

Model Number	SYPHILIS
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8549725
• Report Number: 1823260-2019-90130
• Device Sequence Number: 11288553
• Product Code: LIP
• UDI-Device Identifier: 04015630934881
• UDI-Public: 04015630934881
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• 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
• Operator of Device: No Information
• Device Model Number: SYPHILIS
• Device Lot Number: 33880200
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1