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

Catalog Number 0006446

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 an immucor field personnel reported false negatives on an igg cross-match performed on galileo echo instrument with capture-r select lot sc280.

Manufacturer Narrative

Immucor technical support used remote electronic access method to assess the instrument electronic images.Sample in question reacted negative with multiple lots of capture reagents and different unit samples.Could not rule out sample related issue.

• 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: 4013410
• MDR Text Key: 4708452
• Report Number: 1034569-2014-00151
• 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: 08/14/2014

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: 05/05/2015
• Device Catalogue Number: 0006446
• Device Lot Number: SC280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2014
• Initial Date FDA Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 43 YR