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	07/15/2020
Type of Reportable Event	Malfunction
Additional 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 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, 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: 10368052
• Report Number: 3005967741-2020-00004
• Device Sequence Number: 19580891
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/05/2020

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/05/2020
• 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