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 12/02/2014

Event Type  malfunction  

Event Description

Customer reported to technical specialist that a donor sample typed c+ by serology and c- by hea beadchip.The molecular result has been confirmed by a second molecular test (idcorext, grifols/progenika).

Manufacturer Narrative

12/02/2014 - the sample needs to be tested on the rhce kit and if no variants are detected, it will be sent for sequencing.12/22/2014 - sequencing results not ready.Follow-up report will be sent once sequencing results are ready, 30 calendar days from date of submission of mdr.

• 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: 4350693
• MDR Text Key: 5143372
• Report Number: 3005967741-2014-00004
• 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: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2014
• Device Model Number: 800-10202-08
• Device Catalogue Number: 800-10202-08
• Device Lot Number: 14-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2014
• 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