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	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that lower than expected nt-probnp ii (ntbnp ii) results were obtained when processing a vitros ntbnp ii range verifier (rv) fluid on a vitros 5600 integrated system.An assignable cause of the event was not determined.No information was provided with regards to the customers pre analytical sample handling, therefore, it is possible improper handling of the vitros npbnp ii rv samples during testing contributed to the lower-than-expected vitros ntbnp ii result, although this cannot be confirmed.There is no package insert value assignment or peer data for the mas omni cardio quality control fluids, lot cxl2504la, lot ocrd25031a and lot ocrd25033a with the vitros ntbnp ii assay.Therefore, no assessment can be made about performance of the mas controls in combination with the vitros ntbnp ii assay as it cannot even be confirmed if the baseline means/sds are correctly set.A vitros ntbnp ii reagent issue cannot be confirmed or ruled out as a contributor to this event.Instrument related performance issues did not likely contribute to the event as the customer gave no indication of any instrument malfunction, however, as no diagnostic within run precision testing was performed, an instrument issue cannot be completely ruled out as a potential contributor to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ntbnp ii reagent lot 0100.
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 a vitros ntbnp ii range verifier (rv) fluid on a vitros 5600 integrated system.Vitros npbnp ii rv results of 14642.1, 14692.7, 15523.8, 15595.2 and 16033.2 pg/ml vs expected result of 29400 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 result was obtained when processing vitros ntbnp ii non-patient fluid.The customer made no indication that any patient sample results had been affected.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17565319
• Report Number: 3007111389-2023-00139
• Device Sequence Number: 20499570
• Product Code: NBC
• UDI-Device Identifier: 10758750002061
• UDI-Public: 10758750002061
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/17/2023

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: 08/31/2023
• Device Catalogue Number: 6192255
• Device Lot Number: 0100
• 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: 07/24/2023
• Initial Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown