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

Model Number	800-20202-08
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2005
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported discrepancy between serology and precisetype hea beadchip slide kit.On the same kit, the customer reported two discrepancy samples.The first sample typed c+ with serology but typed c- with precisetype hea beadchip kit.The second sample typed c- with serology but typed c+ with precisetype hea beadchip kit.
Additional Manufacturer Narrative
Not applicable.
Event or Problem Description
Customer reported discrepancy between serology and precisetype hea beadchip slide kit.On the same kit, the customer reported two discrepancy samples.The first sample typed c+ with serology but typed c- with precisetype hea beadchip kit.The second sample typed c- with serology but typed c+ with precisetype hea beadchip kit.

• Brand Name: PRECISETYPE HEA BEADCHIP SLIDE
• 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
• MDR Report Key: 21945777
• Report Number: 3005967741-2025-00004
• Device Sequence Number: 12898577
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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
• Device Expiration Date: 03/31/2026
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 24-228-V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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