FDA Adverse Event Malfunction Summary report: N

SEKISUI DIAGNOSTICS SILARIS FLU PCR

MDR report key: 8604941 · Received May 10, 2019

Report

Report Number: MW5086579
Event Type: Malfunction
Date Received: May 10, 2019
Date of Event: January 1, 2019
Report Date: April 4, 2019
Manufacturer: MESABIOTECH, INC.
Product Code: OZE
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: WA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot
395570	SEKISUI DIAGNOSTICS SILARIS FLU PCR	INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY	OZE	MESABIOTECH, INC.	SILARIS	18052201
395571	SEKISUI DIAGNOSTICS SILARIS FLU PCR	INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY	OZE	MESABIOTECH, INC.	SILARIS	18052201
395572	SEKISUI DIAGNOSTICS SILARIS FLU PCR	INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY	OZE	MESABIOTECH, INC.	SILARIS	18052201
395573	SEKISUI DIAGNOSTICS SILARIS FLU PCR	INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY	OZE	MESABIOTECH, INC.	SILARIS	18052201

Patients

Seq	Age	Sex	Outcome	Treatment
1