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	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2020 immucor technical support used a remote electronic connection method to review test records from the relevant run on the galileo echo v2.0 instrument serial number (b)(4).No errors were noted during processing.The immucor internal record number for this report is pr#(b)(4).
Event or Problem Description
On (b)(6) 2020 a customer reported an unexpected negative antibody screen result on the galileo echo v2.0 instrument.Following the negative screen the patient received two units of rbcs and a delayed serological reaction was noted.

• 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: 9812832
• Report Number: 1034569-2020-00018
• Device Sequence Number: 13605678
• Product Code: KSZ
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/5045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2020

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: 02/04/2020
• Device Catalogue Number: 0066813
• Device Lot Number: R113
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR