MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6192255
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected nt-probnp ii (ntbnp ii) results were obtained when processing non-vitros biorad liquichek cardiac marker plus quality control (qc) fluids lot 1003100 on a vitros 5600 integrated system.Biorad level 2 results of 117.0, 101.7, 97.8 and 106.9 pg/ml vs expected result of 156.2 pg/ml biorad level 3 results of 1782.0 pg/ml vs expected result of 2402.0 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower-than-expected vitros ntbnp ii results were obtained when processing non-vitros qc fluids.The customer made no indication that any patient sample results had been affected, however, ortho cannot conclude that patient samples were not or would not be affected if the event were to recur undetected.There were no reported allegations of harm as a result of this event.This report is number two of three mdrs for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation has determined that lower than expected nt-probnp ii (ntbnp ii) results were obtained when processing non-vitros biorad liquichek cardiac marker plus quality control (qc) fluids lot 1003100 on a vitros 5600 integrated system.An assignable cause of the event was not determined with the information provided.Based on the vitros ntbnp ii quality control results obtained, a reagent performance issue is not likely a contributor to the event.Additionally, continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ntbnp ii reagent lot 0400.The customer declined to carry out any precision testing on the vitros 5600 integrated system.Therefore, an instrument issue cannot be ruled out as contributing to this event.An issue related to the non-vitros biorad quality control fluids cannot be ruled out as a contributor of the event as no information about how the controls were handled and stored after initial use was provided.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21421559
• Report Number: 3007111389-2025-00014
• Device Sequence Number: 7781856
• Product Code: NBC
• UDI-Device Identifier: 10758750033300
• UDI-Public: (01)10758750033300(17)250227(11)240902(10)0400
• Combination Product (Y/N): N
• 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): 02/19/2025

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: 02/27/2025
• Device Catalogue Number: 6192255
• Device Lot Number: 0400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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