MAUDE Adverse Event Report: BIOARRAY SOLUTIONS, LTD. 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	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Initital investigation: lab reported a typing discrepancy between hea beadchip and serology.The donor sample resulted in c positive on hea beadchip kit but donor typed c negative with albaclone and immucor antisera.
Additional Manufacturer Narrative
Initial mdr was submitted on 07-aug-2024.Follow up 001 was submitted on 17-oct-2024.
Event or Problem Description
Initital investigation: lab reported a typing discrepancy between hea beadchip and serology.The donor sample resulted in c positive on hea beadchip kit but donor typed c negative with albaclone and immucor antisera.

• Brand Name: PRECISE TYPE HEA 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 ; 9084449591
• MDR Report Key: 19929438
• Report Number: 3005967741-2024-00004
• Device Sequence Number: 2724995
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 10/17/2024

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: 05/31/2025
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 24-024-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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