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

Model Number 800-10202-08

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

Customer stated they had a c discrepancy.Donor sample typed c+ by hea beadchip and c- by serology.Another vendor ( innotrain ssp) also typed c+.

Manufacturer Narrative

11/18/2014 - dna sample received at reference lab.12/01/2014 - our reference lab performed testing by rhce beadchip, which yielded inconclusive results.Sample is being sent by the reference lab to our (b)(4) location, upon receipt the sample will be sent out for sequencing.Until sequencing results are obtained no final determination can be made regarding whether the hea beadchip was correct or incorrect.Once the analysis is completed a follow-up report will be sent within 30 calendar days after the initial mdr report.

• Brand Name: HEA 1.2 BEADCHIP KIT - SLIDE CE
• Type of Device: HEA 1.2 BEADCHIP KIT - SLIDE CE
• Manufacturer (Section D): BIOARRAY SOLUTIONS LTD.; 35 technology drive; suite 100; warren NJ 07059
• Manufacturer Contact: peter scott ; 35 technology drive; suite 100; warren, NJ 07059 ; 9084449578
• MDR Report Key: 4303894
• MDR Text Key: 5197190
• Report Number: 3005967741-2014-00003
• Device Sequence Number: 1
• Product Code: PEP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2014
• Device Model Number: 800-10202-08
• Device Catalogue Number: 800-10202-08
• Device Lot Number: 13-291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1