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

Model Number	6192255
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, higher than expected ntbnp results were obtained from a single patient sample when tested using vitros nbnp2 lot: 0072 on two vitros 3600 immunodiagnostic systems.The results were discordant when compared to vitros nt-probnp results for the same patient sample.Patient 1, vitros nbnp2 results of 691.79, 650.96 and 607.54 pg/ml versus a vitros nt-probnp result of 63.5 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, higher than expected vitros nbnp2 results were obtained when the customer was processing a patient sample as part of validation of the vitros nbnp2 reagent method at the customer site.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).
Additional Manufacturer Narrative
The investigation determined that discordant, higher than expected ntbnp results were obtained from a single patient sample when tested using vitros nbnp2 lot: 0072 on two vitros 3600 immunodiagnostic systems.The results were discordant when compared to vitros nt-probnp results for the same patient sample.A definitive cause of the event was not established.There was no historical qc data provided to verify vitros nbnp2 performance, therefore a vitros nbnp2 lot: 0072 reagent issue cannot be ruled out as a contributor to the event.However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros nbnp2 lot: 0072.An instrument performance issue is an unlikely contributor to the event as acceptable vitros nt-probnp results were obtained for the patient sample on the same instrument the discordant, higher than expected vitros nbnp2 results were obtained.In addition, a pre-analytical patient sample handling issue is an unlikely contributor to the event as acceptable vitros nt-probnp results were obtained from the same patient sample.Furthermore, patient sample mix up is an unlikely contributor to the event, as from a review of e-connectivity, vitros nbnp2 and vitros nt-probnp testing occurred from the sample tray/cup.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS NT PROBNP II REAGENT
• 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: 16504173
• Report Number: 3007111389-2023-00040
• Device Sequence Number: 6297305
• Product Code: NBC
• UDI-Device Identifier: 10758750033300
• UDI-Public: 10758750033300
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/08/2023

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: 05/05/2023
• Device Model Number: 6192255
• Device Catalogue Number: 6192255
• Device Lot Number: 0072
• 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: 02/08/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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