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 Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of false negative results for 2 patient samples tested for elecsys syphilis (syphilis) on a cobas e 411 immunoassay analyzer.Patient 1 initial result was 1.11 coi (positive).The repeat result was 0.1 coi (negative).The sample was repeated again with a result of 13.7 coi (positive).Patient 2 initial result was 1.06 coi (positive).The repeat result was 0.1 coi (negative).The sample was repeated again with a result of 37.0 coi (positive).No questionable results were reported outside of the laboratory.The e411 analyzer serial number was (b)(4).

Manufacturer Narrative

The calibration information provided by the customer shows that the customer signals were slightly low but within the expected ranges.Sample material was requested for further investigation but was not provided by the customer.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
• MDR Report Key: 9775365
• MDR Text Key: 220318854
• Report Number: 1823260-2020-00607
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: SYPHILIS
• Device Catalogue Number: 06923348190
• Device Lot Number: 413714
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1