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	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On july 22, 2019 immucor technical support used a remote electronic connection method to assess files on galileo echo v2.0 instrument serial number (b)(4); the camera report was acceptable.July 23, 2019 immucor confirmed presence of the e antigen on cell 2 of retention capture-r ready-screen 3 lot number r067 in manual capture retention using capture-r ready indicator cells lot number 221869 with retention anti-e lot ab4929.Controls performed as expected.Cell 2 resulted positive as expected.Retention product performed as expected.On july 24, 2019 immucor performed an antibody screen on returned patient sample with an echo lumena using retention capture-r ready-screen 3 lot number r067 and capture-r ready indicator cells lot number 221869.Controls performed as expected and return sample resulted positive with cell2 (e+e=).The customer issue was not reproduced.Retention product performed as expected.The immucor internal report record number for this report is mdr723820.
Event or Problem Description
On july 22, 2019 a customer reported an unexpected negative screen result using capture-r ready-screen 3 on the galileo echo v2.0 instrument.

• 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: 8847366
• Report Number: 1034569-2019-00124
• Device Sequence Number: 2499144
• Product Code: KSZ
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/31/2019

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 Catalogue Number: 0066813
• Device Lot Number: R067
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/31/2019
• 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