MAUDE Adverse Event Report: MESABIOTECH, INC. SEKISUI DIAGNOSTICS SILARIS FLU PCR; INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY

Model Number SILARIS

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/01/2019

Event Type  malfunction  

Event Description

Sekisui product: silaris, ref # 1027 by mesabiotech, influenza a and b pcr.This product produces erroneous and or no results 40% of the runs, when directions were followed in package insert and instruction manual by sekisui.This has been reported to sekisui diagnostics and they have reported it to mesabiotech.All sekisui test kits and dock stations to run the influenza a and b tests have been returned to sekisui diagnostics.Sekisui is aware of the resulting issues with this machine and device and they have been sent examples of cassettes that do not result or when the machine says "invalid test" or says "test device not inserted" even when it is inserted properly.Photos of run cassettes with no results and no qc control line.

• Brand Name: SEKISUI DIAGNOSTICS SILARIS FLU PCR
• Type of Device: INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY
• Manufacturer (Section D): MESABIOTECH, INC.
• MDR Report Key: 8604941
• MDR Text Key: 145092479
• Report Number: MW5086579
• Device Sequence Number: 3
• Product Code: OZE
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/22/2019
• Device Model Number: SILARIS
• Device Catalogue Number: 1027
• Device Lot Number: 18052201
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1