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	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019 immucor technical support used a remote electronic connection method to assess files on galileo echo v2.0 instrument serial number (b)(4); no errors were seen during testing and the camera report was within specification.On july 23, 2019 immucor technical support used a remote electronic connection method to assess files on galileo echo v2.0 instrument serial number (b)(4); no errors were seen during testing and the camera report was within specification.On july 26, 2019 immucor confirmed presence of the k antigen on cell 3 of retention capture-r ready-screen lot number r076 in manual capture using retention capture-r indicator cell 221357 with retention anti-k lot k012512f-2.Controls performed as expected.Cell 3 resulted positive as expected.Retention product performed as expected.The immucor internal report record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported an unexpected negative screen results with capture-r ready-screen 3 on the galileo echo v2.0 instrument.

• Brand Name: CAPTURE-R READY-SCREEN (3)
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8912027
• Report Number: 1034569-2019-00130
• Device Sequence Number: 11112764
• Product Code: KSZ
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 102707/5045
• 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): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: 0066813
• Device Lot Number: R076
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1