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 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

Interpretation: the m and n antigens are associated with the polymorphism, c.59 c>t, in exon 2 of the gypa gene1,2.By sanger sequencing analysis, reading from one direction the sample is heterozygous, c.59c/t, predicting the m and n antigens.However, reading from the other direction the sample is homozygous, c.59c, predicting the m antigen.This ambiguity is likely due to a gyp hybrid originating in or around intron 2 as shown in the right image aligned to gypa (ng_007470) and gypb (ng_007483) reference sequences that abrogates precisetype hea test primer binding leading to a n(0) result on beadchips (b)(4).Gyp hybrids are listed as a limitation of the precisetype hea test.(b)(4).

Event Description

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

• 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: 10101123
• MDR Text Key: 205290157
• Report Number: 3005967741-2020-00003
• 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: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 19-370-V
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1