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

Catalog Number 06923348190

Device Problem Low Test Results (2458)

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

Event Date 04/28/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)# (b)(4).The event occurred in: (b)(6).

Event Description

The customer complained of a (b)(6) result for 1 patient sample tested on a cobas e 411 immunoassay analyzer compared to other test methods and the patient's clinical symptoms.The initial (b)(6) result from the cobas e411 was (b)(6) and then was (b)(6) tested with treponema pallidum particle agglutination assay (tppa).The sample was then retested on a cobas e411 with a (b)(6) result.The rapid plasma reagin (rpr) result for the sample was (b)(6).The sample was then again tested using tppa and was (b)(6).The sample was also tested on an abbott system with a weak (b)(6) result.The result from a colloidal gold test strip was also a strong (b)(6).(b)(6) results of (b)(6) were provided, but it was not known which specific results were the initial or the repeat result.The customer stated the patient had a history of exposure and was considered a high risk.Along with the clinical symptoms of the patient, skin chancre, the patient was confirmed positive for syphilis.The cobas e411 serial number was (b)(4).Qc results on the cobas e411 were good.The investigation is currently ongoing.

Manufacturer Narrative

Further investigation of the information provided found there was no indication of an assay performance issue.The patient sample was not available for further investigation.A negative elecsys syphilis result does not completely rule out the possibility of an infection with syphilis.Serum or plasma samples from the very early phase or the late phase of a syphilis infection can occasionally yield negative findings.The investigation was unable to find a definitive root cause.

• 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
• MDR Report Key: 7511123
• MDR Text Key: 108724431
• Report Number: 1823260-2018-01486
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• PMA/PMN Number: K160910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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: 09/30/2018
• Device Catalogue Number: 06923348190
• Device Lot Number: 277571
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/28/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 04/28/2018
• Supplement Dates FDA Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1