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

Model Number	800-20202-08
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HEA 1.2 BEADCHIP KIT, PLATE
• Manufacturer (Section D): BIOARRAY SOLUTIONS LTD.; 35 technology drive; suite 100; warren NJ 07059
• MDR Report Key: 10101123
• Report Number: 3005967741-2020-00003
• Device Sequence Number: 14407246
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BP130026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1