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 Codes	Chest Pain (1776); Chills (2191)
Date of Event	09/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor offered to have an immucor field service engineer inspect the instrument and perform reactions checklist, but customer declined and stated that this is a sample related issue.No product or sample was returned to immucor for further investigation.The internal immucor record for this event is (b)(4).
Event or Problem Description
On (b)(6) 2021 a customer reported an unexpected negative antibody screen result for pre-transfusion sample with using capture-r ready-screen 3 on an echo lumena instrument and a hemolytic transfusion reaction with one patient.Customer stated that this is a sample related issue.

• 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
• MDR Report Key: 12566238
• Report Number: 1034569-2021-00024
• Device Sequence Number: 11072662
• Product Code: QHT
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: BL 102707
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

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: 10/26/2021
• Device Catalogue Number: 0066813
• Device Lot Number: R279
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 10/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 67