FDA.reportPublic FDA data

MAUDE MDR 7138047

MDR report key
7138047
Report number
3005967741-2017-00029
Event key
0
Event type
3
Date of event
2017-12-07
Date received
2017-12-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
105
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LUZ VILLAMIZAR
Address
35 TECHNOLOGY DRIVE SUITE 100 WARREN NJ 07059 US
Phone
908-908-9084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HEA 1.2 BEADCHIP KIT, SLIDEHEA 1.2 BEADCHIP KIT, SLIDEBIOARRAY SOLUTIONS LTD.PEP800-20202-08800-20202-0818-11-VY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-210

Event Narratives#

N

Patient 1

SEQUENCING INTERPRETATION: THE RESULTS OF PRECISETYPE HEA BEADCHIP HEAE9353_2 REPRESENT A HETEROZYGOUS JKAB INDIVIDUAL1. HOWEVER, THE INDIVIDUAL IS ALSO HETEROZYGOUS FOR A POLYMORPHISM OF THE INTRON 5 SPLICE ACCEPTOR SITE (IVS5AS, ISBT=JK*02N.01, ALSO KNOWN AS C.342-1G>A) THAT SILENCES THE EXPRESSION OF THE JKB ANTIGEN. THE SILENCING OF JKB, AS FIRST REPORTED BY LUCIEN ET AL.2, WOULD LEAVE NO EXPRESSION OF THE JKB ANTIGEN ON THE SURFACE OF THE ERYTHROCYTE. JKNULL IS LISTED AS A LIMITATION OF THE PRECISETYPE? HEA BEADCHIP TEST AS LISTED IN THE PACKAGE INSERT (PART NUMBER 190-20210).

D

Patient 1

THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS JKB+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE JKB-.