MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN 3; AUTOMATED BLOOD BANK SYSTEM

Catalog Number	0066813
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support was unable to use a remote electronic connection method to assess files, but copies of the reports were provided by the customer for assessment.On september 5, 2019 a field service engineer inspected galileo neo serial number (b)(4)and found no issues with the instrument.The immucor internal report record number for this report is (b)(4).
Event or Problem Description
On august 24, 2019 a customer reported unexpected negative antibody screen results on the galileo neo and galileo echo instruments, resulting in a patient having a delayed transfusion reaction after receiving antigen-positive units.

• Brand Name: CAPTURE-R READY-SCREEN 3
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 9167725
• Report Number: 1034569-2019-00131
• Device Sequence Number: 17006248
• Product Code: KSZ
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BL102707
• 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): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/10/2019
• Device Catalogue Number: 0066813
• Device Lot Number: R075
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2019
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR