MAUDE Adverse Event Report: BIOARRAY SOLUTIONS, LIMITED PRECISETYPE HEA MOLECULAR BEADCHIP KIT; MOLECULAR ERYTHROCYTE TYPING TEST

Model Number 800-20202-96

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Event Description

Customer reported two (2) fya- discrepancies.

Event Description

On (b)(6) 2022, the customer reported that two (2) fya- discrepancies occured while testing with hea lot#22-141-v.The customer informed bioarray's technical support specialist that sample (b)(4) typed fya- on plate heam5976_g3 and typed fya+ on slide heam0135_8.This was noticed and results were not released however sample (b)(4) on plate heam5986_f8 resulted in fya-, but was only discovered to be discordant with previous typing performed at nybc on plate heal4061_e11.

• Brand Name: PRECISETYPE HEA MOLECULAR BEADCHIP KIT
• Type of Device: MOLECULAR ERYTHROCYTE TYPING TEST
• Manufacturer (Section D): BIOARRAY SOLUTIONS, LIMITED; 35 technology drive; suite 100; warren NJ 07059
• Manufacturer (Section G): BIOARRAY SOLUTIONS, LIMITED; 35 technology drive; suite 100; warren NJ 07059
• Manufacturer Contact: jesdeep sidhu ; 35 technology drive; suite 100; warren, NJ 07059 ; 9084449591
• MDR Report Key: 16099354
• MDR Text Key: 308276985
• Report Number: 3005967741-2022-00005
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 10888234102618
• UDI-Public: 10888234102618
• 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: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Model Number: 800-20202-96
• Device Catalogue Number: 800-20202-96
• Device Lot Number: 22-141-V
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• 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
• Patient Outcome(s): Other