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	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Interpretation: the molecular presence of adenine at the polymorphic site that is indicative of the kidd (jk) antigen represents a homozygous jk(a- b+) individual1, as was reported by hea beadchips heai7153_7 and heai7174_6.However, the individual is also heterozygous for a polymorphism at c.810g>a in exon 7 (rs17675299) that could silence the expression of the jkb antigen2.This is a case where a sample contains a molecular event that affect the blood-group antigen expression, and the nucleotide change associated with this event are not explicitly monitored by the hea assay as described in the package insert (part number 190-20210).
Event or Problem Description
The customer reported a possible discrepancy.The donor is jkb+ using the bioarray hea molecular beadchip kit; serology results were jkb-.

• 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: 10950689
• Report Number: 3005967741-2020-00006
• Device Sequence Number: 16319213
• 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): 12/04/2020

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: 11/05/2020
• Initial Report FDA Received Date: 12/05/2020
• 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