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 Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

Sequencing interpretation: the sample is heterozygous at c.676g>c which is consistent with a e+e+ individual1,2.The sample is also heterozygous for a nonsense mutation at rhce c.221g>a ((b)(6)) which would cause a premature stop codon.All exons for rhce were sequenced.It is probable that the truncated protein which is a result of the nonsense mutation is causing the discrepancy between precisetype hea beadchip (b)(6) phenotype results and serology results.It is recommended that the other rhce results are also confirmed serologically.

Event Description

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

• 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: 7855408
• MDR Text Key: 119936283
• Report Number: 3005967741-2018-00010
• 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: 09/06/2018

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
• 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
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 09/07/2018
• 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