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	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a possible discrepancy.The donor is k+ using the bioarray hea molecular beadchip kit; serology results were k-.
Event or Problem Description
The customer reported a possible discrepancy.The donor is k+ using the bioarray hea molecular beadchip kit; serology results were k-.
Additional Manufacturer Narrative
Interpretation: molecular presence of guanine at the polymorphic site, c.230g, of the bcam gene encoding the lutheran (lu) antigens, represents a homozygous lub individual1, as was reported by hea beadchip heai9054_8.Sequencing of bcam gene intron 2, exons 3, 5 and 6 did not identify polymorphisms associated with the lu null phenotypes2.The klf1 gene, with 3 exons, encodes the erythroid krüppel-like factor 1 (or eklf1).Although the eklf1 is not a blood group antigen, it is known that variations in the klf1 gene are associated with the in(lu) phenotypes, which are characterized by reduced expression of the lu antigens2.The klf1 gene of the sample was also pcramplified and sequenced using both in-house design and the singleton design3.The sample is heterozygous c/g at the polymorphic site, rs3817621, located at 210 nucleotides upstream of the transcription start site.This klf1 variant is known to be associated with reticulocyte fraction of the red cells4.Sequencing of exons 1 and 3 did not identify any polymorphisms associated with in(lu) phenotypes2.However, use of three different primer pairs, including the in-house and the singleton designs, could not amplify the fragment between the intron 1 and the 3' end of exon 2, which suggests presence of unknown polymorphisms in this region of the klf1 gene associated with the in(lu) phenotypes2.In summary, this sample may have a novel klf1 variant with heterozygous c/g at rs3817621 and unknown polymorphisms in between intron 1 and exon 2, which could be related to lack of lub expression.The klf1 variants for the in(lu) phenotypes are not detectable in the hea beadchip assay as described in the package insert.

• 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: 12324478
• Report Number: 3005967741-2021-00003
• Device Sequence Number: 3736161
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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,Followup
• Report Date (Section B): 08/26/2021

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: 07/31/2021
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 19-393-C
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/01/2021
• 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