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	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected nbnp2 results were obtained when a level 3 biorad qc fluid was processed using vitros nbnp2 lot 2200 and lot 2230 on a vitros 3600 immunodiagnostic system.A definitive cause of the event was not established.Low bias was observed from both levels of biorad qcs (level 2 and level 3) processed by the customer.The customer suspected a potential issue with the biorad qcs, however, this could not be confirmed.In addition, the customer did not process a qc closer to the lower end of the vitros nbnp2 amr.Therefore, the performance of the vitros nbnp2 reagent at the low end of the amr could not be verified.Qc results since the customer put into use vitros nbnp2 lot 2245 showed improved accuracy but unacceptable precision.The customer was sent vitros nbnp2 controls, however, at the time of writing this investigation, no results from vitros nbnp2 control testing have been provided.No precision testing was performed on the instrument, so it was not possible to verify the performance of the instrument at the time of the event.Therefore, an instrument issue cannot be completely ruled out as contributing to the event, although, there is no evidence or any suggestion from the customer that the instrument was not performing as intended.No information was provided in relation to the handling of the biorad qcs; therefore, improper qc fluid handling cannot be ruled out as a contributor to the event.Ongoing tracking and trending of complaint data did not identify any signals to suggest there is a systemic quality issue with vitros nbnp2 lot 2200 or lot 2230.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected nbnp2 results were obtained when a level 3 biorad qc fluid was processed using vitros nbnp2 lot 2200 and lot 2230 on a vitros 3600 immunodiagnostic system.Biorad lot 1003123 (level 3), vitros nbnp2 lot 2200 results of 1217.34, 1163.83, 1173.65, 1212.79, 1211.16, 1167.65, 1155.88 and 1160.77 pg/ml versus the baseline mean result of 1636.0 pg/ml biorad lot 1003123 (level 3), vitros nbnp2 lot 2230 results of 1189.34, 1155.1, 1162.1, 1129.16 and 1091.87 pg/ml versus the baseline mean result of 1636.0 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 nbnp2 results were obtained when the customer was processing non-patient fluids.There has been no allegation of patient 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).

• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24290939
• Report Number: 3007111389-2026-00029
• Device Sequence Number: 9397630
• Product Code: NBC
• UDI-Device Identifier: 10758750033300
• UDI-Public: (01)10758750033300(17)260408(11)251010(10)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: 04/08/2026
• Device Catalogue Number: 6192255
• Device Lot Number: 2200
• 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: 01/12/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2025
• 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