MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN 3; REAGENT RED BLOOD CELLS

Model Number	CAPTURE-R READY-SCREEN 3
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 a customer site in the uk reported that they had received unexpected negative results for an antibody screen using capture-r ready-screen 3 on the european version of the neo iris instrument.
Additional Manufacturer Narrative
On (b)(6) 2022 the 3_cell assay was performed by immucor on neo 5030090014 using retention strips of capture-r ready-screen 3 (cw) lot e482 and retention vial of capture-r ready indicator red cells lot number 221085 with 6 known in-house donor samples of which 3 were known negative and 3 were known positive (anti-(fy(a), anti- cw, anti-d).All samples reacted as expected.Qc3_cell passed as expected.The retention product performed as expected.In this investigation, the customer issue was not reproduced or confirmed.Retention product performed as expected.No patient harm was reported.No defect or deficiency was found with the capture-r ready-screen 3 device; it was determined that the device was operating as designed and within the known limitations described in labeling.No remedial action is required.The event has been attributed to the sample, where the antibodies detected by gelcard technology appear to be wholly igm in nature; and any igg component of the antibodies occurs below the detection capability of capture-r ready-screen 3.The following limitations regarding the specimen apply as described in the instructions for use for capture-r ready-screen 3 (ifu 387-5) : specificities of presumed significance, that are wholly igm in nature (ie, igm anti-k or igm anti-e) may fail to react in this assay.According to "the blood group antigen facts book.M.E.Reid etal., elsevier 2022" alloanti-cw as well as alloanti-fy(b) can occur as igm antibodies.Negative reactions will be obtained if the test serum contains antibodies present in concentrations too low to be detected by the test methods employed.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
• Manufacturer Contact: howard yorek ; 3130 gateway drive; po box 5625; norcross, GA 30091-5625 ; 6784184738
• MDR Report Key: 16041119
• Report Number: 1034569-2022-00019
• Device Sequence Number: 6238096
• Product Code: KSZ
• UDI-Device Identifier: 10888234001461
• UDI-Public: 10888234001461
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: CAPTURE-R READY-SCREEN 3
• Device Catalogue Number: 0066814
• Device Lot Number: E428
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 12/23/2022
• 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 Sex: Unknown