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	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Interpretation: the sample is heterozygous at c.48g>c and homozygous at c.307c, c.676g, 733c and c.1006g as well as homozygous for the c-linked intronic marker consistent with a c+c+e-e+v-vs- individual1,2.All exons for rhce were sequenced.Nonspecific polymorphisms at the c-linked intronic marker is likely due to an upstream intronic snp at dbsnp 28677062 g>c, which would explain the c- phenotype with precisetype hea beadchip heai0482_2 and heai7064_8 results.
Event or Problem 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
• 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: 9792572
• Report Number: 3005967741-2020-00002
• Device Sequence Number: 2176767
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/05/2020

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: 09/30/2020
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 19-200-V
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1