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 Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

Sequencing results interpretation: the molecular presence of both guanine and adenine at c.125 in the absence of the silencing polymorphism at ackr1 -67 and weakening polymorphism at c.265 (not pictured) typically represents a fy*01/02 (fya+b+) individual,2, as reported by precisetype hea beadchips heae0908_2 and heaf8917_7.Several polymorphisms in the 5'utr were also found at ackr1 c.-673t>a ((b)(4)), ackr1 c.-248t>a, and ackr1 c.-69t>c (fy*01.08).The polymorphism at c.-69t>c has been previously identified in literature as a fya-silencing allele3.Null and silencing alleles are listed as limitations within the precisetype hea molecular beadchip package insert.

Event Description

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

• 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: 7569075
• MDR Text Key: 110585725
• Report Number: 3005967741-2018-00006
• 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: 06/05/2018

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: No Information
• Device Expiration Date: 05/31/2019
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 18-281-V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1