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

Model Number	800-20202-08
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005967741-2022-00012
• Device Sequence Number: 5640067
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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