MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN 3; REAGENT RED BLOOD CELLS

Catalog Number	0066813
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On march 16, 2020 immucor technical support used a remote electronic connection method to review assay records on the instrument.No errors occurred at time of testing and rois are centered and aligned.Review showed cells 1 and 3 are visually negative, and cell 2 resulted (b)(6) but shows slight adherence (but well score was not high enough to give it an equivocal result).The immucor internal record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2020 a customer reported an unexpected negative antibody screen with capture-r ready-screen 3 on the galileo neo instrument.

• Brand Name: CAPTURE-R READY-SCREEN 3
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross, ga
• MDR Report Key: 9955535
• Report Number: 1034569-2020-00022
• Device Sequence Number: 2789717
• Product Code: KSZ
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 102707/5045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2020

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: No Information
• Device Expiration Date: 05/26/2020
• Device Catalogue Number: 0066813
• Device Lot Number: R133
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR