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

Model Number 800-20202-96

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

Patient Problem No Code Available (3191)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

Sequencing results interpretation: the existence of cytosine and thymine at the polymorphic site that is indicative of the kpa/kpb antigens in the kel gene represents a heterozygous kpa+b+ individual1.An interfering polymorphism was responsible for the kpb- results on hea beadchip carriers heab5939_g6, heac1464_4 and heac1464_5.This polymorphism has been previously identified as c.846g>c (prior nucleotide numbering is c.966g>c; rs8175993), no clinical associations could be found in published literature.Interfering mutations are listed as a limitation in the precisetype hea molecular test package insert.This sample was previously investigated on may 5, 2016 with identical results via this id program.

Event Description

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

• Brand Name: HEA 1.2 BEADCHIP KIT, SLIDE
• Type of Device: HEA 1.2 BEADCHIP KIT, SLIDE
• Manufacturer (Section D): BIOARRAY SOLUTIONS LTD.; 35 technology drive; suite 100; warren NJ 07059
• Manufacturer Contact: luz villamizar ; 35 technology drive; suite 100; warren, NJ 07059 ; 9084449591
• MDR Report Key: 7877978
• MDR Text Key: 120716315
• Report Number: 3005967741-2018-00013
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2015
• Device Model Number: 800-20202-96
• Device Catalogue Number: 800-20202-96
• Device Lot Number: 16-23
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1