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

Model Number	800-20202-08
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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 or Problem 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.
Additional Manufacturer Narrative
Initial mdr was filed on 12jan2024; follow up 001 was filed on 07mar2024; follow up 002 was filed on 16aug2024.

• Brand Name: PRECISETYPE HEA MOLECULAR BEADCHIP KIT
• Common Device Name: 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
• Report Number: 3005967741-2024-00001
• Device Sequence Number: 12728569
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BP130026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2024

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: Health Professional
• Device Expiration Date: 08/31/2024
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 12/13/2023
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 03/07/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown