MAUDE Adverse Event Report: BIOARRAY SOLUTION LTD. PRECISETYPE HEA MOLECULAR BEADCHIP TEST KIT; MOLECULIAR ERYTHROCYTE TYPING TEST

Model Number 800-20202-08

Device Problem False Positive Result (1227)

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

Event Date 08/25/2022

Event Type  malfunction  

Event Description

Donor who has typed as c negative multiple times by serology (manual and automated) that is testing positive with hea.Molecular results tested multiple times with 2 different extractions.

Manufacturer Narrative

Health care provider reported donor who has typed as c negative multiple times by serology (manual and automated, all immucor reagents) that is testing positive with hea.Molecular results tested multiple times with 2 different extractions.

• Brand Name: PRECISETYPE HEA MOLECULAR BEADCHIP TEST KIT
• Type of Device: MOLECULIAR ERYTHROCYTE TYPING TEST
• Manufacturer (Section D): BIOARRAY SOLUTION LTD.; 35 technology drive, suite#100; warren NJ 07059 5148
• Manufacturer Contact: jesdeep sidhu ; 35 technology drive, suite#100; warren, NJ 07059-5148 ; 9084449591
• MDR Report Key: 15480722
• MDR Text Key: 306277653
• Report Number: 3005967741-2022-00012
• 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
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 21-105-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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