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	06/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 a customer reported that they had received a negative antibody screen result with capture-r ready-screen 3 on their neo iris instrument.The patient received a transfusion, and a delayed serological reaction was observed.Subsequently anti-c and anti-jkb were identified.
Additional Manufacturer Narrative
On (b)(6) 2023 an immucor field service engineer (fse) examined neo iris instrument serial number (b)(6) onsite and performed a successful unexpected reaction checklist.The fse performed qc (group and screen) and received the expected results (five samples ran: four resulted with expected results and one resulted as no_int with cell 3 due to an equivocal (customer confirmed sample is positive for antibodies).On (b)(6) 2023 immucor used remote access to review the results for sample id (b)(6) from (b)(6) 2023.No instrument problems were noted.The internal immucor reference for this event is (b)(4).

• 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: 17347473
• Report Number: 1034569-2023-00013
• Device Sequence Number: 5205936
• Product Code: QHT
• UDI-Device Identifier: 10888234000648
• UDI-Public: 10888234000648
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/18/2023

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: 08/01/2023
• Device Catalogue Number: 0066813
• Device Lot Number: R486
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/18/2023
• 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: 34 YR
• Patient Sex: Male