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

Model Number	6192255
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, lower than expected nt-probnp (nbnp2) results were obtained when a customer processed multiple patient samples using vitros nbnp2 lot 0050 on a vitros xt7600 integrated system.The results were discordant when compared to vitros nt-probnp lot 3170 results for the same patient samples tested at the same time on the same vitros xt7600 integrated system.Patient 1, vitros nbnp2 result of 173.23 pg/ml versus the vitros nt-probnp result of 240.85 pg/ml patient 2, vitros nbnp2 result of 172.94 pg/ml versus the vitros nt-probnp result of 242.39 pg/ml patient 3, vitros nbnp2 result of 3009.34 pg/ml versus the vitros nt-probnp result of 4039.31 pg/ml patient 4, vitros nbnp2 result of 176.29 pg/ml versus the vitros nt-probnp result of 258.69 pg/ml patient 5, vitros nbnp2 result of 175.09 pg/ml versus the vitros nt-probnp result of 250.84 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, lower than expected vitros nbnp2 results were obtained when the customer was performing a patient correlation for menu expansion.No patient sample vitros nbnp2 results were reported from the laboratory.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).
Additional Manufacturer Narrative
The investigation determined that discordant, lower than expected nt-probnp (nbnp2) results were obtained when a customer processed multiple patient samples using vitros nbnp2 lot 0050 on a vitros xt7600 integrated system.The results were discordant when compared to vitros nbnp2 lot 3170 results for the same patient samples tested at the same time on the same vitros xt7600 integrated system.A definitive cause of the discordant, lower than expected vitros nbnp2 results was not established.Historical qc results were acceptable leading up to the event, therefore a vitros nbnp2 lot 0050 reagent assay issue is an unlikely contributor to the event.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros nbnp2 lot 0050.Despite potential instrument issues around the time of the event, an issue with the vitros xt7600 integrated system is an unlikely contributor to the event as the vitros nt-probnp results for the patients were deemed acceptable from testing on the same instrument.Furthermore, discordant lower than expected vitros nbnp2 patient sample results were obtained prior to and following ortho field engineer service actions on the instrument.In addition, improper storage of the patient samples is an unlikely contributor to the event, as acceptable vitros nt-probnp results were obtained from the same samples for the patients.However, the ortho tsc recommended further patient correlation testing to occur with samples within the stability claims set out in the vitros nbnp2 ifu.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS NT PROBNP 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: 16493969
• Report Number: 3007111389-2023-00038
• Device Sequence Number: 15044628
• Product Code: NBC
• UDI-Device Identifier: 10758750033300
• UDI-Public: 10758750033300
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/02/2023

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: 02/27/2023
• Device Model Number: 6192255
• Device Catalogue Number: 6192255
• Device Lot Number: 0050
• 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: 02/03/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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