MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY INDICATOR RED CELLS; QUALITY CONTROL KITS FOR BLOOD BANKING REAGENTS

Catalog Number	0006427
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On march 27, 2019 immucor technical support used a remote electronic connection method to assess files on galileo neo instrument serial number (b)(4); the camera report was acceptable and the event log indicated no errors at time of testing.Images appear as called by the neo.Rois are centered, no adjustment was needed.On april 1, 2019 an immucor field service technician inspected galileo neo instrument serial number (b)(4) at the customer facility.The technician performed an unexpected reaction check list for the instrument, then replaced syringes for probes 1 and 2, and replaced lamp for camera reader.The immucor internal report record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported unexpected negative antibody screening results with capture-r ready-screen 3 on the galileo neo instrument.

• Brand Name: CAPTURE-R READY INDICATOR RED CELLS
• Common Device Name: QUALITY CONTROL KITS FOR BLOOD BANKING REAGENTS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8533251
• Report Number: 1034569-2019-00078
• Device Sequence Number: 16463228
• Product Code: KSF
• UDI-Device Identifier: 10888234000594
• UDI-Public: 10888234000594
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK020053
• 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): 04/19/2019

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: 03/21/2019
• Device Catalogue Number: 0006427
• Device Lot Number: 221274
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/19/2019
• 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