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	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full customer telephone extension number is (b)(6).Immucor technical support used a remote electronic connection method on 20oct2017 to assess the instrument test well images in question, and determined that the instrument test well images in question were visually negative.An immucor field service engineer visited the customer site to assess the testing instrument used on 24oct2017 and found it to be operating as expected.
Event or Problem Description
On (b)(6) 2017, a (b)(6) customer site reported an unexpected negative compatible crossmatch when using capture-r select strips on a galileo neo instrument, under a validation challenge scenario.

• 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: 7026305
• Report Number: 1034569-2017-00307
• Device Sequence Number: 1184359
• Product Code: KSF
• UDI-Device Identifier: 10888234000655
• UDI-Public: 10888234000655
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK040024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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: 07/30/2018
• Device Catalogue Number: 0006446
• Device Lot Number: SC521
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR