FDA.reportPublic FDA data

MAUDE MDR 7208997

MDR report key
7208997
Report number
MW5074677
Event key
0
Event type
3
Date of event
2017-12-20
Date received
2018-01-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1ANORA COLLECTION KITKIT, CULTURE, CHROMOSOME.NATERAKIQANORA FRESH3927289-2-POCE08118,7067962,F013019,1864553I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-190

Event Narratives#

D

Patient 1

UPON OPENING THE ANORA, NATERA, SINGLE NUCLEOTIDE POLYMORPHISM (SNP) MICROARRAY CHROMOSOME ANALYSIS COLLECTION KIT IN THE OPERATING ROOM, I NOTICED THE SPECIMEN CONTAINER INSIDE THE KIT DID NOT HAVE NSS SOLUTION IN IT. IT APPEARED THE SOLUTION HAD LEAKED UT BECAUSE THERE WERE STILL DROPLETS OF A SOLUTION INSIDE THE CONTAINER. I DECIDED TO DISCARD THE KIT AND USE A NEW NATERA KIT AS I WASN'T SURE IF THE CONTAINER INTEGRITY HAD BEEN COMPROMISED. MISCARRIAGE.