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

Catalog Number	0006446
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on (b)(6) 2016 to assess the instrument test well image in question, which visually appeared negative.The immucor laboratory tested retention product on (b)(6) 2016, which performed as expected.The immucor laboratory also received returned blood sample from the customer site, and tested it on (b)(6) 2016.This blood sample testing yielded unexpected compatible results, and it therefore did not perform as expected.
Event or Problem Description
On (b)(6) 2016, an on-site immucor employee, at a customer site, reported some unexpected negative compatible crossmatch results when using capture-r select on a galileo echo instrument.

• Brand Name: CAPTURE-R SELECT
• Common Device Name: SOLID PHASE SYSTEM FOR THE IMMOBILIZATION OF HUMAN ERYTHROCYTES
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6100075
• Report Number: 1034569-2016-00294
• Device Sequence Number: 10836506
• Product Code: KSZ
• UDI-Device Identifier: 10888234000655
• UDI-Public: 10888234000655
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BK040024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2016

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
• Operator of Device: Medical Technologist
• Device Expiration Date: 05/16/2017
• Device Catalogue Number: 0006446
• Device Lot Number: SC438
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1