FDA.reportPublic FDA data

MAUDE MDR 8604941

MDR report key
8604941
Report number
MW5086579
Event key
0
Event type
3
Date of event
2019-01-01
Date received
2019-05-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SEKISUI DIAGNOSTICS SILARIS FLU PCRINFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAYMESABIOTECH, INC.OZESILARIS102718052201 R
2SEKISUI DIAGNOSTICS SILARIS FLU PCRINFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAYMESABIOTECH, INC.OZESILARIS102718052201 *
3SEKISUI DIAGNOSTICS SILARIS FLU PCRINFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAYMESABIOTECH, INC.OZESILARIS102718052201 *
4SEKISUI DIAGNOSTICS SILARIS FLU PCRINFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAYMESABIOTECH, INC.OZESILARIS102718052201 *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-100

Event Narratives#

D

Patient 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.