MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. 0.8% SURG 3X10ML; REAGENT RED BLOOD CELLS

Model Number	6902316
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/25/2022
Type of Reportable Event	Death
Event or Problem Description
(b)(4) investigation: as part of the investigation, retain testing for vss420, batch record review and complaint review were performed.All results met criteria and ortho was unable to reproduce the event.An ortho field engineer went on site on (b)(4) 2022, performed the following checks - incubator, centrifuge and fluidic system - and confirmed the analyzer was working as intended.An ortho 2nd level personnel went on site on (b)(4) 2023 to: collect information from the customer and internal reports to inspect the samples provided by the customer (for this issue and that of cms (b)(4)) -to run qc that passed -to pull laboratory information system logs files, common logs (uploaded to axeda) and screenshots from the analyzer settings configuration.Further investigation was performed by ortho 2nd level.Three documents were created by ortho personnel and were shared with the customer during a conference call that was held on (b)(6) 2023.These documents summarize the timeline and sequence of the 2 events in question (cms (b)(4)) as ortho understand them.They were developed from various sources of data, which include but not limited to information in the complaint files, information from customer and internal reports, information from e-connectivity analysis and a site visit by 2nd level personnel.Findings/hypothesis: sample id (b)(6) was tested twice for antibody screening in iat using 0.8% surgiscreen lot vss420 and a 3+ reaction was obtained with cell 1 in the initial testing (negative in the repeat testing); the positive antibody screening was automatically sent to the customer laboratory information system and manually archived at the analyzer level -re-use of barcode labels for different patient samples -inconsistencies for sample volumes in sample containers between the different tests performed -manual entries of sample barcodes in some instances -orders manually created whereas no pending orders from the lis -inconsistent plasma appearance (color) in sample containers between the different tests performed.Although a definitive assignable cause of the discrepant negative antibody screening test could not be determined, it is speculated that sample processing and testing errors that occurred at the customer facility are the cause of the discrepancy.The customer is working with their risk management since after all of the investigations conducted by ortho and themselves, the root cause of the alleged discrepant negative antibody screening result was due to a human error.Customer reported discrepant negative antibody screening result for 1 patient having an anti-k(kel1) antibody.The assigned cause of the alleged discrepant negative antibody screening result was due to a human error.No general product failure is identified.A biased result was reported to the physician.The patient experienced a transfusion reaction and expired.
Additional Manufacturer Narrative
Customer reported discrepant negative antibody screening result for 1 patient having an anti-k(kel1) antibody.The assigned cause of the alleged discrepant negative antibody screening result was due to a human error.No general product failure is identified.A biased result was reported to the physician.Health effect-clinical code: code 4581 used (appropriate code not available).Need term for transfusion reaction and patient death the patient experienced a transfusion reaction and expired.

• Brand Name: 0.8% SURG 3X10ML
• 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: 16214233
• Report Number: 0002250051-2023-00036
• Device Sequence Number: 19946928
• Product Code: QHT
• UDI-Device Identifier: 10758750007660
• UDI-Public: 10758750007660
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/20/2023

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: 12/24/2022
• Device Model Number: 6902316
• Device Catalogue Number: 6902316
• Device Lot Number: VSS420
• 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: Not provided
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2016
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown