MAUDE Adverse Event Report: BIOARRAY SOLUTIONS, LTD. PRECISETYPE HEA MOLECULAR BEADCHIP KIT; PRECISE TYPE HEA BEADCHIP KIT

Model Number 800-20202-08

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Event Description

Customer reported about jkb discrepancy.Customer stated patient result is jk(b-) on precisetype hea beadchip kit and a different molecular platform.Same sample tests jk(b+) with two serologic tests.

Event Description

Customer reported about jkb discrepancy.Customer stated patient result is jk(b-) on precisetype hea beadchip kit and a different molecular platform.Same sample tests jk(b+) with two serologic tests.

• Brand Name: PRECISETYPE HEA MOLECULAR BEADCHIP KIT
• Type of Device: PRECISE TYPE HEA BEADCHIP KIT
• Manufacturer (Section D): BIOARRAY SOLUTIONS, LTD.; 35 technology drive; suite 100; warren NJ 07059
• Manufacturer (Section G): BIOARRAY SOLUTIONS, LTD; 35 technology drive; suite 100; warren NJ 07059
• Manufacturer Contact: jesdeep sidhu ; 35 technology drive; suite 100; warren, NJ 07059
• MDR Report Key: 18503916
• MDR Text Key: 333329541
• Report Number: 3005967741-2024-00001
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 23-162-V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1