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 view the results of the relevant tests.Images were reviewed for capture-r ready-screen 3 assay on (b)(6) 2023.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 for the capture-r ready-id assay on (b)(6) 2023 were also reviewed; and all wells have tightly defined and dense cell buttons.Wells 7 and 8 have very slight adherence.Well 13 has a smaller defined cell button and slight adherence, an equivocal reaction.Images reviewed in this complaint were as expected with respect to the interpretation on the instrument.It is suspected that the patient had a newly formed anti-k as a result of a recent previous transfusion (i.E.Prior to (b)(6) 2023).This newly formed antibody may have been mostly or wholly igm in nature, such that any igg component was below the level of detection of the assays.The intended use of the capture products is detection of igg antibodies; and the ifu's cite the following applicable limitation "specificities of presumed significance, that are wholly igm in nature (i.E., igm anti-k or igm anti-e) may fail to react in this assay".On (b)(6) 2023, immucor confirmed presence of the k antigen on cell 3 of retention capture-r ready-screen 3 lot r451 by capture using retention capture-r indicator cell lot 221232 with retention anti-k lot 054035.Controls performed as expected.Positive results exhibited 4+ reactivity.Retention product performed as expected.No defect or deficiency was identified for either the instrument or the assay reagents.This is a sample related issue.The internal immucor reference for this event is pr#954447.
Event or Problem Description
On (b)(6) 2023, a customer stated that a patient had a transfusion reaction following receipt of one unit of k+ blood.

• 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: 16679202
• Report Number: 1034569-2023-00008
• Device Sequence Number: 12759715
• Product Code: QHT
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/5045
• 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): 04/04/2023

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: 04/09/2023
• 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: 03/06/2023
• Initial Report FDA Received Date: 04/04/2023
• 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 Age: 36 YR
• Patient Sex: Male