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	Jaundice (2187)
Date of Event	10/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor received 1 tube with 2.0 ml plasma and 1 tube with 0.5 ml red cells.Both tubes were labeled (b)(6).On (b)(6) 2021 immucor confirmed presence of the k antigen on cell 1 of retention capture r ready screen lot r292 by capture method capture using retention capture-r indicator cell 221886 with retention anti-k lot 054020.Controls performed as expected.Positive results exhibited 4+ reactivity.Retention product performed as expected.On (b)(6) 2021 immucor confirmed presence of the c antigen on cell 1 of retention capture r ready screen lot r292 in manual capture using retention capture-r indicator cell 221886 with retention anti-c lot dl23472.Controls performed as expected.Positive results exhibited 4+ reactivity.Retention product performed as expected.On (b)(6) 2021 immucor confirmed presence of the e antigen on cell 2 of retention capture r ready screen lot r292 by capture method capture using retention capture-r indicator cell 221886 with retention anti-e lot 053020.Controls performed as expected.Positive results exhibited 4+ reactivity.Retention product performed as expected.On (b)(6) 2021 immucor confirmed presence of the s antigen on cells 1 and 2 of retention capture r ready screen lot r292 by capture method capture using retention capture-r indicator cell 221886 with retention anti-s lot 622008-aa controls performed as expected.Positive results exhibited 4+ reactivity.Retention product performed as expected.On (b)(6) 2021 immucor confirmed presence of the fya antigen on cells 1 and 2 of retention capture r ready screen lot r292 by capture method capture using retention capture-r indicator cell 221886 with retention anti-fya lot 055020.Controls performed as expected.Positive results exhibited 4+ reactivity.Retention product performed as expected.On (b)(6) 2021 immucor performed an antibody screen on the echo lumena with return sample (b)(6) sample using retention capture r ready screen lot r292 and retention capture-r indicator cells lot 221886.Controls performed as expected and return sample (b)(6) resulted 1+ positive with cell 2 (e+e=).On (b)(6) 2021 immucor performed an antibody id on the echo lumena with return sample (b)(6) sample using retention capture r ready id lot id422 and retention capture-r indicator cells lot 221886.Controls performed as expected and return sample (b)(6) resulted 1+ positive with cell 3 (e+e=) and negative with cell 1 (e+e+) and cell6 (e+e+).There are no additional complaints of unexpected negative reactivity for capture r ready screen lot r292.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 v2.0 instrument and a delayed transfusion reaction with one patient.

• 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
• Manufacturer Contact: howard yorek ; 3130 gateway drive; po box 5625; norcross, GA 30091-5625 ; 6784184738
• MDR Report Key: 12879735
• Report Number: 1034569-2021-00029
• Device Sequence Number: 4950108
• Product Code: QHT
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2021

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: 12/07/2021
• Device Catalogue Number: 0066813
• Device Lot Number: R292
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/27/2021
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 59 KG