MAUDE Adverse Event Report: BIOARRAY SOLUTIONS, LTD. PRECISETYPE HEA BEADCHIP

Model Number	800-20202-96
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Initial description on 27mar2025: customer reported fy(a-) typing discrepancy for two different samples on position g8 and position f9 using precisetype hea beadchip plate (p/n 800-20202-96).The customer tested both samples with serology and the results typed fy(a+).The customer reran the samples using precisetype hea beadchip slide (p/n 800-20202-08) using lot# 24-075 for plate position g8 and lot#24-186 for plate position f9.Both re-run results typed fy(a+), matching serology.
Additional Manufacturer Narrative
Note: the complaint device or kit was not available for further investigation.Bioarray did review the adjusted intensity data by comparing the complaint chips using the precise type hea beadchip plate lot and the retest chips using the precise type hea beadchip slide lot.
Event or Problem Description
Initial description on 27mar2025: customer reported fy(a-) typing discrepancy for two different samples on position g8 and position f9 using precisetype hea beadchip plate (p/n (b)(4)).The customer tested both samples with serology and the results typed fy(a+).The customer reran the samples using precisetype hea beadchip slide (p/n (b)(4)) using lot# 24-075 for plate position g8 and lot#24-186 for plate position f9.Both re-run results typed fy(a+), matching serology.

• Brand Name: PRECISETYPE HEA BEADCHIP
• Common Device Name: PRECISETYPE HEA BEADCHIP
• 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: 21713784
• Report Number: 3005967741-2025-00001
• Device Sequence Number: 10130779
• Product Code: PEP
• UDI-Device Identifier: 10888234102618
• UDI-Public: 10888234102618
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 09/30/2025
• Device Model Number: 800-20202-96
• Device Catalogue Number: 800-20202-96
• Device Lot Number: 24-064-V
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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