MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (2); REAGENT RED BLOOD CELLS

Catalog Number	0006440
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On march 7, 2019 immucor technical support used a remote electronic connection method to review test records from the relevant run on the neo instruments serial number (b)(4).Review of the event log for both instruments show no errors during test event and review of the roi's for both test plates show that the roi's were not misaligned.On march 8, 2019 an immucor service technician inspected neo instrument serial number (b)(4) and performed an unexpected reaction checklist and the instrument was found to be operating within specifications.The internal immucor record for this event is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported unexpected negative screen results using capture-r ready-screen 2 on the neo instrument.

• Brand Name: CAPTURE-R READY-SCREEN (2)
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8471164
• Report Number: 1034569-2019-00066
• Device Sequence Number: 16634912
• Product Code: KSZ
• UDI-Device Identifier: 10888234000648
• UDI-Public: 10888234000648
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/01/2019

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: 03/20/2019
• Device Catalogue Number: 0006440
• Device Lot Number: X493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1