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

Model Number 800-20202-08

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2018

Event Type  malfunction  

Event Description

The customer reported a possible discrepancy.The donor is fya- using the bioarray hea molecular beadchip kit; serology results were fya+.

Manufacturer Narrative

Fda mdr team requested manufacturer to resubmit this follow-up report with the investigation summary report.

Event Description

The customer reported a possible discrepancy.The donor is fya(-) using the bioarray precise type hea molecular beadchip kit.Serology results were fya (+).

• Brand Name: PRECISE TYPE HEA BEADCHIP KIT
• Type of Device: PRECISE TYPE HEA BEADCHIP KIT
• Manufacturer (Section D): BIOARRAY SOLUTIONS, LTD.; 35 technology drive; suite# 100; warren NJ 08060
• 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: 7855810
• MDR Text Key: 119936318
• Report Number: 3005967741-2018-00009
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 18-304-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2018
• 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