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	Chills (2191)
Date of Event	05/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2021 an immucor field service engineer inspected echo lumena instrument serial number (b)(4) at the customer site.The immucor field service engineer performed an unexpected reaction checklist.Immucor advised customer that the issue appears to be sample related.Customer advised of the following limitation 12 in the package insert: some igg antibodies have been shown to react poorly in solid phase red blood cell adherence assays.These include examples of antibodies to bga, bgb, kna, csa, yka, jmh, mcca, ch and rg.The internal immucor record for this event is (b)(4).
Event or Problem Description
On (b)(6) 2021 a customer reported that a patient had a suspected febrile hemolytic reaction when receiving part of one blood unit that was electronically cross matched based on negative echo lumena screen result.

• 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: 11953906
• Report Number: 1034569-2021-00017
• Device Sequence Number: 3648394
• Product Code: QHT
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 06/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2021
• Device Catalogue Number: 0066813
• Device Lot Number: R236
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 100