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 Code Available (3191)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 19may2017 to assess the instrument test well images in question, which visually appeared positive, with a hole in the center of the test well red blood cell monolayer.The immucor laboratory tested retention product on 25may2017, which performed as expected.The immucor laboratory also received returned blood sample from the customer site, and tested it on 25may2017 and 02jun2017.The testing performed on 25may2017 yielded the same unexpectedly positive weak d outcome, consistent with the customer site findings.The testing performed on 02jun2017 this time yielded the expected weak d negative outcomes.A direct antiglobulin test (dat) was performed on both 25may2017, and also 02jun2017, which yielded a negative outcome both times.
Event or Problem Description
On 19may2017, a customer site reported an unexpected weak d positive outcome when using capture-r select on a galileo neo instrument, when tested on (b)(6) 2017.The record was subsequently deemed to be reportable to fda on 24may2017.

• 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: 6658012
• Report Number: 1034569-2017-00115
• Device Sequence Number: 13967917
• Product Code: KSZ
• UDI-Device Identifier: 10888234000655
• UDI-Public: 10888234000655
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK040024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 06/21/2017

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: 02/08/2018
• Device Catalogue Number: 0006446
• Device Lot Number: SC474
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR