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

Model Number 800-20202-96

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2019

Event Type  malfunction  

Event Description

The customer reported a possible discrepancy.The donor is c+ using the bioarray hea molecular beadchip kit; serology results were c-.

Manufacturer Narrative

Rhce exon 2 analysis: by using the exon 2 amplification primers published by haer-wigman et al (2013)1, the sample is homozygous c.307c indicative of c+ phenotype in both forward and reverse sequences as shown in the sequencing report.To verify above sequencing result, the sample was also amplified by two sets of rhce exon 2 primers followed by sanger sequencing using three primers published by volkova et al (2019)2.The 1.3 kb f3-r1 amplicon from the sample generates the scrambled sequence using the seqf1-s sequencing primer.The 1.7 kb f4-r4 pcr product generates the scrambled sequence from the forward primer seqf4, and a readable sequence from the reverse primer seqr4 indicative of homozygous c.307t as shown below.In sanger sequencing, the scramble sequencing read from a pcr amplicon is due to undesignated polymorphism in the amplicon sequence, pcr primer and/or sequencing primer regions in one or two alleles of the target gene.All exons of the rhce gene have been sequenced for this sample.Except for exon 2 encoding the rhc antigen, the sequencing results are consistent with hea tests for the c+ e+ e- v- vs- phenotypes.Further investigation will be required to determine root cause for the conflict rhc phenotype in sequencing as well as in hea assay.

Event Description

The customer reported a possible discrepancy.The donor is c+ using the bioarray hea molecular beadchip kit; serology results were c-.

• Brand Name: HEA 1.2 BEADCHIP KIT, PLATE
• Type of Device: HEA 1.2 BEADCHIP KIT, PLATE
• Manufacturer (Section D): BIOARRAY SOLUTIONS LTD.; 35 technology drive; suite 100; warren NJ 07059
• MDR Report Key: 9503506
• MDR Text Key: 191919811
• Report Number: 3005967741-2019-00018
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (y/n): N
• PMA/PMN Number: BP130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Model Number: 800-20202-96
• Device Catalogue Number: 800-20202-96
• Device Lot Number: 19-96-V
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1