MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY INDICATOR RED CELLS; KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS

Model Number	0006427
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Fever (1858)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, a customer reported a suspected delayed transfusion reaction with a patient whose samples were initially negative by screen and id, but anti-s was identified with later sample.
Additional Manufacturer Narrative
During investigations with retained product, immucor did not reproduce the customer issue with our in-house samples.It is suspected that the anti-s was initially igm only and was able to bind indicator cell lot 221989 directly but not lot 221978.Indicator cells are made up of a pool of donors so possible that 221989 had more s+ cells than 221978.The internal immucor reference for this event is (b)(4).
Additional Manufacturer Narrative
During investigations with retained product, immucor did not reproduce the customer issue with our in-house samples.It is suspected that the anti-s was initially igm only and was able to bind indicator cell lot 221989 directly but not lot 221978.Indicator cells are made up of a pool of donors so possible that 221989 had more s+ cells than 221978.The internal immucor reference for this event is (b)(4).The medical device report was reported march 2, 2022 in order to be submitted within the required 30-day timeline.However, the investigation of the event was not complete at that time, so report #1034569-2022-00005 was submitted based on the partial information available at that time.A supplement to report #1034569-2022-00005 has now been submitted which states that the issue was sample-related and is a known limitation of the capture technology which is clearly described in the instructions for use.On (b)(6) 2022, the affected patient received 3 units of blood.On (b)(6) 2022 the patient received 1 unit of blood and a febrile transfusion reaction was noted.On (b)(6) 2022, the patient received 1 unit of blood and another transfusion reaction was observed; the doctors at the site attributed this reaction down to taco (transfusion associated circulatory overload).Taco cannot be prevented by immunologic screening.On march 17, 2022, the customer notified immucor that they had received results back from a reference lab.The sample was tested by reference lab who detected anti-s.Dtt treatment of the plasma showed a clear reduction in antibody activity but not completely negative.This suggests the antibody in this sample is primarily igm.The significant igm component of the antibody indicates that it was newly formed, and the igg component was below the level of detection of the assay.Per the capture-r ready-screen (3) instructions for use: "capture-r ready-screen (3) is intended for use in the detection of unexpected igg antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods."; "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."; "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 adverse event described in report #1034569-2022-00005 was determined to be isolated and caused by the condition of the affected patient.The immucor product was determined to be operating within acceptable performance parameters (and limitations).
Event or Problem Description
On february 2, 2022, a customer reported a suspected delayed transfusion reaction with a patient whose samples were initially negative by screen and id, but anti-s was identified with later sample.

• Brand Name: CAPTURE-R READY INDICATOR RED CELLS
• Common Device Name: KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS
• 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: 13657144
• Report Number: 1034569-2022-00005
• Device Sequence Number: 12008207
• Product Code: KSF
• UDI-Device Identifier: 10888234000594
• UDI-Public: 10888234000594
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: BK020053
• 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,Followup
• Report Date (Section B): 06/27/2022

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: 02/06/2022
• Device Model Number: 0006427
• Device Catalogue Number: 0006427
• Device Lot Number: 221978
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 06/27/2022
• 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