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	Transfusion Reaction (4596)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2023 immucor used remote access to review images from m20401 for sample (b)(6).This sample had buttons that were tightly defined and dense for wells 1-3.Wells 1 and 3 had very slight adherence with well 3 exhibiting more adherence than the other wells.The reaction images were analyzed and well 3 was on the threshold of detection due to the size of the button with respect to the background.Images reviewed in this complaint were as expected with respect to the interpretation on the instrument.On (b)(6) 2023 immucor performed a screen assay on the echo lumena using 2 known antibody negative in house donor samples with retention crrs3 lot r451 and retention crrirc lot 221215.This testing was to show that no non-specific reactivity was taking place on the plate.Controls performed as expected, and the 2 in house samples resulted negative as expected.Retention product performed as expected.Identified anti-k was weakly expressed (1+) and may be newly formed (resulting from multiple past transfusions) or largely igm in nature (capture technology does not reliable detect igm; intended use is detection of igg).The internal immucor reference for this event is pr#: (b)(4).
Event or Problem Description
On (b)(6) 2023 a customer reported unexpected negative reactivity (missed anti-k) with capture-r ready-screen 3 on their 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 30071
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• MDR Report Key: 16587906
• Report Number: 1034569-2023-00007
• Device Sequence Number: 12236139
• Product Code: QHT
• UDI-Device Identifier: 10888234000648
• UDI-Public: 10888234000648
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2023
• Device Catalogue Number: 0066813
• Device Lot Number: R451
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown