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

Model Number 800-20202-08

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/18/2019

Event Type  malfunction  

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 individual1, as was reported on precisetype hea beadchip heah0731_1.However, the individual is also homozygous 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).

Event Description

The customer reported a possible discrepancy.The donor is jkb+ using the bioarray hea molecular beadchip kit; serology results were jkb-.

Manufacturer Narrative

Interpretation: the molecular presence of both guanine and adenine at the polymorphic site indicative of the jka/b antigen would normally represent a heterozygous jkab individual1, as reported by precisetype hea beadchips heag8698_7 and heag8699_3.However, the individual is also heterozygous for a polymorphism at c.956c>t in exon 10 (p.Thr319met; rs1058396; jk*01n.04) that silences the expression of the jka antigen.The silencing of jka, as first reported by wester et al.2, would leave no expression of the jka 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).- attachment: [(b)(4)-investigation report summary lifestream 101523374.Pdf].

Event Description

The customer reported a possible discrepancy.The donor is jka+ using the bioarray hea molecular beadchip kit; serology results were jka-.

• Brand Name: HEA 1.2 BEADCHIP KIT, SLIDE
• Type of Device: HEA 1.2 BEADCHIP KIT, SLIDE
• Manufacturer (Section D): BIOARRAY SOLUTIONS LTD.; 35 technology drive; suite 100; warren NJ 07059
• MDR Report Key: 8551492
• MDR Text Key: 151771461
• Report Number: 3005967741-2019-00005
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (y/n): N
• PMA/PMN Number: BP130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2020
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 19-21-V
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1