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

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 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

Interpretation: the molecular presence of guanine and adenine at the polymorphic site that is indicative of the kidd (jk) antigen represents a heterozygous jk(a+b+) individual 1, as was reported by hea beadchips (b)(4)_7 and (b)(4)_7.However, the individual is also homozygous for a polymorphism at c.588a>g in exon 6 (rs2298718) that could weaken the expression of the jka and jkb antigens2,3,4.Using sequence-specific primer pcr and bi-directional sanger sequencing analysis, this individual is c.28g in exon 3, c.226g and c.303g in exon 4, and c.588a in exon 6 demonstrating lack of the jk*01n.20 [jk(a-b-)] variant5.This is a case where a sample contains a molecular event that affect the blood-group antigen expression, and the nucleotide changes associated with this event are not explicitly monitored by the hea assay as described in the package insert (part number 190-20210).(b)(4).

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, PLATE
• Type of Device: HEA 1.2 BEADCHIP KIT, PLATE
• 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: 10368052
• MDR Text Key: 205290436
• Report Number: 3005967741-2020-00004
• 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: Other
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2020
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 19-137-V
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening