MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R SELECT; SOLID PHASE SYSTEM FOR THE IMMOBILIZATION OF HUMAN ERYTHROCYTES

Catalog Number 0006446

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/11/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, a customer reported unexpected compatible crossmatch results when using capture-r select on a galileo neo instrument on (b)(6) 2014.

Manufacturer Narrative

Immucor technical support used remote electronic access method to assess the galileo neo electronic images on (b)(4) 2014.The well images for the unexpected crossmatch compatible wells all appeared as unexpected negative with associated tightly defined red blood cell buttons.Immucor laboratory tested retention products on (b)(4) 2014 and all retention products performed as expected.The customer returned blood samples to immucor for testing, and on (b)(4) 2014 the immucor laboratory duplicated the unexpected compatible crossmatch results.The unexpected crossmatch compatible results have a potential for a transfusion error.

• Brand Name: CAPTURE-R SELECT
• Type of Device: SOLID PHASE SYSTEM FOR THE IMMOBILIZATION OF HUMAN ERYTHROCYTES
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 562
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 562
• Manufacturer Contact: howard yorek ; 3130 gateway drive; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 3734631
• MDR Text Key: 20696708
• Report Number: 1034569-2014-00057
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 04/07/2014

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: Medical Technologist
• Device Expiration Date: 01/25/2015
• Device Catalogue Number: 0006446
• Device Lot Number: SC262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2014
• Initial Date FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 66