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

Catalog Number	0006446
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 12jun2018 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 on 12jun2018 to assess the two (2) testing instruments used and found them both to be operating as expected.Complaints of positive reactions being interpreted as negative by the galileo echo camera algorithm are being corrected under design control project (b)(4).The echo instruments are performing as expected with the exception of the camera module ability to appropriately identify some true positive results.The immucor technical communication (b)(4) is being used by the lab to visually confirm all negative assay events reported by the echo instruments.(b)(4).
Event or Problem Description
On 31may2018, a customer site reported an unexpected negative compatible crossmatch when using capture-r select strips on two (2) galileo echo instruments, when tested on (b)(6) 2018.

• 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: 7638978
• Report Number: 1034569-2018-00152
• Device Sequence Number: 1818421
• Product Code: KSF
• UDI-Device Identifier: 10888234000655
• UDI-Public: 10888234000655
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/26/2018

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: 03/18/2019
• Device Catalogue Number: 0006446
• Device Lot Number: SC558
• 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: 05/31/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR