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

Model Number	800-20202-08
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 heak3856_5 and heak3393_4.However, the individual is also heterozygous for a polymorphism at c.588a>g in exon 6 ((b)(4)) that could weaken the expression of the jka or jkb antigens2,3.This is a case where a sample contains a molecular event that affects 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 hea package insert (part number 190-20210).
Event or Problem 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, SLIDE
• Common Device Name: HEA 1.2 BEADCHIP KIT, SLIDE
• Manufacturer (Section D): BIOARRAY SOLUTIONS LTD.; 35 technology drive; suite 100; warren NJ 07059
• MDR Report Key: 12367317
• Report Number: 3005967741-2021-00004
• Device Sequence Number: 19711905
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/25/2021

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: 09/30/2022
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 21-2-V
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening