MAUDE Adverse Event Report: BIOARRAY SOLUTIONS LTD. HEA 1.2 BEADCHIP KIT, SLIDE

Model Number 800-20202-08

Device Problem False Negative Result (1225)

Patient Problem No Information (3190)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

Sequencing results interpretation: the molecular presence of only cytosine at the polymorphic site indicative of the ss antigen represents an s-s+, individual 1,2 as reported by precisetype hea beadchips heaf1792_6 and heaf1785_8.No other polymorphisms were observed that would affect expression however sequencing for other sites in the gypb gene were unresolvable which may be consistent with a hybrid or deletion event.Molecular events affecting expression, including gyp hybrids, are listed as limitations in the precisetype hea molecular test package insert.

Event Description

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

• Brand Name: HEA 1.2 BEADCHIP KIT, SLIDE
• Type of Device: HEA 1.2 BEADCHIP KIT, SLIDE
• Manufacturer (Section D): BIOARRAY SOLUTIONS LTD.; 35 technology drive; suite 100; warren NJ 07059
• Manufacturer Contact: luz villamizar ; 35 technology drive; suite 100; warren, NJ 07059 ; 9084449591
• MDR Report Key: 7596576
• MDR Text Key: 111687432
• Report Number: 3005967741-2018-00007
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2018
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 18-96-V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1