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

Model Number 800-20202-08

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

Discrepancy 1 results: sample (b)(6).The molecular presence of mixed base adenine and guanine at the polymorphic site that is indicative of the kidd (jk) antigen would normally represent a heterozygous jk(a+b+) individual1, as was reported by hea bead chips heac4321_6 and head7186_1.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).The adenine at this site could silence the expression of the jkb antigen from the same allele.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).Discrepancy 2 results: sample (b)(6).The molecular presence of only adenine at the polymorphic site that is indicative of the kidd (jk) antigen would normally represent a homozygous jk(b+) individual1, as was reported by hea bead chips head7188_8 and head8258_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 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 bead chip test as listed in the package insert (part number 190-20210).

Event Description

The customer reported two possible discrepancies.The donor is jkb+ using the bioarray hea molecular bead chip kit; serology results were jkb-.

• 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
• Manufacturer Contact: luz villamizar ; 35 technology drive; suite 100; warren, NJ 07059 ; 9084449591
• MDR Report Key: 6682136
• MDR Text Key: 79141218
• Report Number: 3005967741-2017-00021
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• 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: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2017
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 17-50-V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• 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