MAUDE Adverse Event Report: BIOARRAY SOLUTIONS LTD. HEA 1.2 BEADCHIP KIT, SLIDE CE

Model Number 800-10202-08

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/16/2015

Event Type  malfunction  

Event Description

Customer reported an jkb typing discrepancy with the bioarray hea v1.2 beadchip kit.

Manufacturer Narrative

Interpretation: the molecular presence of only adenine at the polymorphic site that is indicative of the kidd (jk) antigen would normally represent a homozygous jkb individual, as was reported by hea beadchips heaa8633_7 and heab0665_5.However, the individual is also homozygous for a polymorphism of the intron 5 splice acceptor site (ivs5as, isbt=jk*02n.01, also known as 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).From the package insert: false positives and/or invalid results may be generated in rare cases where a sample contains examples of molecular events that affect the blood group antigen expression and phenotypes, (suchas, dna sequence variations including premature codon, snp leading to missence change in amino acid, hybrid genes; changes at the rna transcription level including alternative splicing; reuced protein expression, etc.) and the nucleotide changes associated with these events are not explicitly monitored by the assay.Known phenotypes are knull (jknull has a prevalence of up to 9% amoung polynesians ) rhnull, rh hybrids, kmod, co(a-b-), in(lu), lu(a-b-) gp hybrids.Precence of c.179_180del (ser60fs) mutation linked with the fy(b) allele may change the fy(b) antigen expression and lead to a false positive call.

• Brand Name: HEA 1.2 BEADCHIP KIT, SLIDE CE
• Type of Device: HEA 1.2 BEADCHIP KIT, SLIDE CE
• Manufacturer (Section D): BIOARRAY SOLUTIONS LTD.; 35 technology drive; suite 100; warren NJ 07059
• Manufacturer Contact: peter scott ; 35 technology drive; suite 100; warren, NJ 07059 ; 9084449578
• MDR Report Key: 4902665
• MDR Text Key: 6069710
• Report Number: 3005967741-2015-00010
• Device Sequence Number: 1
• Product Code: PEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2016
• Device Model Number: 800-10202-08
• Device Catalogue Number: 800-10202-08
• Device Lot Number: 15-31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1