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

Model Number 800-20202-08

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Sequencing interpretation: sample (b)(6): the results of precisetype hea beadchip heaf2280_5 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).Sample (b)(6): the results of precisetype hea beadchip heaf2280_3 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).

Event Description

The customer reported a possible discrepancy.Two donor samples type jkb+ using the bioarray hea molecular beadchip 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: 7137926
• MDR Text Key: 96127149
• Report Number: 3005967741-2017-00028
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2018
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 18-96-V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• 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