MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN

Catalog Number	6902315
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Hyperbilirubinemia (1903)
Date of Event	09/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) windchill (b)(6) on (b)(6)2023, a customer contacted the global technical support center to report a delayed hemolytic transfusion reaction as a result of discordant negative antibody reactions of the antibody screening for one patient having an anti-c and anti-k antibodies using 0.8% selectogen lot vs537, expiry 19sep2023, in conjunction with mts anti-human globulin anti-igg (rabbit) gel card lot 061223001-17, expiry 26apr2024, with the ortho vision analyzer (b)(6).Complainant/complaint reporter: (b)(6) ¿ laboratory supervisor (b)(6), (b)(6).Date of event: original testing - (b)(6) 2023, identified discordant results ¿ (b)(6) 2023 reported on: (b)(6)2023 reagents: 0.8% selectogen lot vs537, expiry 19sep2023, manufacture date 18jul2023 mts anti-igg gel card lot 061223001-17, expiry 26apr2024, manufacture date 26jul2023 0.8% selectogen lot vs542, expiry 17oct2023, manufacture date 15aug2023 0.8% resolve panel a lot vra440, expiry 03oct2023 patient information: patient had a prior history of aus (antibody of unknown specificity) reported in (b)(6)2023 as per customer.Patient diagnosis at the time of initial testing was right shoulder pain.Patient was transfused with two units of crossmatch compatible blood on (b)(6)2023.Delayed transfusion reaction workup was initiated on (b)(6)2023 as a result of elevated bilirubin levels (between 0.30 and 0.50) over multiple collections between (b)(6).No further information was provided as to what medical interventions or treatment was used to manage the transfusion reaction, but the patient is recovered as per the customer.The customer reported that the original patient sample was collected and tested on (b)(6)2023, for antibody screening using 0.8% selectogen lot vs537 and mts anti-igg gel card lot 061223001-17.Results were negative for both cells.On the same day, the same sample was used to perform immediate spin and ahg crossmatch testing with two donor units.Both results were compatible.On (b)(6)2023, customer initiated a delayed transfusion reaction investigation on the patient as the patient had elevated bilirubin levels sustained since the transfusion of the two crossmatched units of blood.The site¿s procedure for delayed transfusion reaction investigation requires repeat testing of the initial ¿pre¿ sample (collected (b)(6)2023).Repeat testing of the sample for antibody screening with alternate lot, 0.8% selectogen lot vs452 and same lot, mts anti-igg card lot 061223001-17 produced a positive result of screening cell 2 (1+).Further testing of the ¿pre¿ sample for antibody identification using 0.8% resolve panel a lot vra440 with mts anti-igg card lot 061223001-17 produced positive (1+) reactions of cells 1, 2, 3, 5, 7, and 10, and positive (2+) reaction of the auto control well.Cells 4, 6, 8, 9 and 11 were negative.The customer stated that anti-c and anti-k antibodies were identified for the patient.Antigen typing of the patient using the ¿pre¿ sample was negative for c and k.Patient dat: igg ¿ positive, c3 ¿ negative.The customer typed the transfused unit.It was c (+), c (+) and k (-).Patient¿s bilirubin has been between 0.30-0.50 over multiple collection between (b)(6).Customer states patient is recovered.No additional details provided by the customer regarding patient testing or treatment provided.
Additional Manufacturer Narrative
Customer reported quality control testing were as expected on the day of events.Reagent storage and handling conditions were as per ifu.According to ortho lot-specific information for 0.8% selectogen lot vs537, cell 1 is positive and homozygous for c antigen and cell 2 is negative for c antigen.Therefore, the negative reactions obtained are not consistent with the expected reactivity of an anti-c antibody.Additionally, cell 2 is positive and heterozygous for k antigen and cell 1 is negative for k antigen.Therefore, the negative reactions obtained are not consistent with the expected reactivity of an anti-k antibody.As part of the investigation, review of the manufacturing batch records for 0.8% selectogen lot vs537 was performed.Manufacturing batch record review did not identify any non-conformance or quality event that could be related to the issue reported by the customer.All in-process testing met release criteria.The reagent red cell was expired at the time of customer report, no retain testing could be performed.Donor history files for donors (b)(6) and (b)(6) were reviewed.Donor (b)(6) donated for 7 product lots up to (b)(6) 2023.Donor (b)(6) donated for 4 product lots up to (b)(6) 2023.A query of the worldwide complaint databases was performed for products manufactured from donor (b)(6) and (b)(6).No trends identified.A query of the worldwide complaint databases was performed for product lot.No trend identified.As per ortho¿s medical safety team, the following consultation was provided: based on the provided information, the subject pre-transfusion antibody screen missed the anti-c and k antibodies in the patient and was transfused with c (+) blood.The c antigen is part of the rhesus (rh) blood group antigen.Rh antibodies are alloantibodies produced after exposure to antigen-positive blood or blood products.The circulating titers may wane over time because these antibodies are not naturally occurring, leading to missed identification during the antibody screen.However, they are still capable of causing hemolytic transfusion upon re-exposure to corresponding antigen-positive blood.Anti-c antibodies have been implicated in dhtrs through igg-mediated hemolysis but are incapable of activating the complement system.Thus, this potential dhtr may be due to the missed anti-c antibody in the patient.Based on liu and grossman 2013, aus may represent developing antibodies that are clinically significant.Their findings showed that aus disappeared in some patients while some developed new antibodies, including anti-c antibodies.Based on the provided information, this event appears mild, considering that the total bilirubin is within the normal range (0.1 ¿ 1.2 mg/dl), and there was no evidence of increasing bilirubin.Also, without any information that suggests patient hospitalization or prolongation of hospitalization, advanced patient care due to hemolysis, and worsening anemia, this case is assessed as mild dhtr.The risk of serious patient injury is remote.In mitigation of this complaint, the ifu states: for antibody detection and identification, different serological methods are optimal for different antibodies.No single antibody screening or identification method optimally detects all antibodies.In some low ionic strength test systems, certain anti-e and anti-k antibodies have been reported to be nonreactive.Assignable cause of the discordant negative results obtained in antibody screening by the customer for this patient sample is sample related, the sample¿s anti-c and anti-k antibodies being weak and/or at the detection limit of the technique and reagents used and/or associated to the variability of the c and k antigens present on the reagent red blood cells.A delayed hemolytic transfusion reaction was reported, however the risk of serious patient injury is remote.

• Brand Name: ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18021213
• Report Number: 0002250051-2023-00127
• Device Sequence Number: 6538784
• Product Code: QHT
• UDI-Device Identifier: 10758750007653
• UDI-Public: 10758750007653
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2023
• Device Catalogue Number: 6902315
• Device Lot Number: VS537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown