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	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2020 immucor technical support used a remote electronic connection method to review test records from the relevant run on the echo lumena instrument serial number (b)(4).No errors were noted during processing.On february 28, 2020 immucor confirmed presence of the e antigen on cell #2 of retention capture-r ready-screen 3 lot r123 in manual capture using retention capture-r indicator cell 221498 with retention anti-e lot dl23523.Controls performed as expected.All e positive cells tested resulted positive as expected.Retention product performed as expected.The immucor internal record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2020 a customer reported an unexpected (b)(6) antibody screen result on the echo lumena 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
• MDR Report Key: 9813230
• Report Number: 1034569-2020-00019
• Device Sequence Number: 610508
• 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): 03/10/2020

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: 02/04/2020
• Device Catalogue Number: 0066813
• Device Lot Number: R113
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR