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

Catalog Number	1072693
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower-than-expected nt-probnp ii (ntbnp ii) result was obtained when processing a non-vitros biorad liquichek cardiac markers plus control lt quality control (qc) fluid lot 1003102 on a vitros 5600 integrated system.Biorad qc lot 1003102 qc fluid result of 51.0 pg/ml versus the expected result of 153.2 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 non-patient fluid.The customer made no indication that any patient sample results had been affected.There were no reported allegations of 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 has determined that a lower than expected nt-probnp ii (ntbnp ii) result was obtained when processing a non-vitros biorad liquichek cardiac markers plus control lt quality control (qc) fluid lot 1003102 on a vitros 5600 integrated system.The assignable cause of the lower than expected qc fluid result was a transient issue with the vitros signal reagent pack in use.A signal reagent (sr) was suspected to contribute to lower than expected vitros ntbnp ii results.An on-site investigation was conducted, including data collection and comparison of the vitros ntbnp ii reagent performance with other vitros microwell reagents.Temperature monitoring confirmed sr pack storage conditions were between 3.9 degrees celsius and 5.1 degrees celsius, meeting the required 2-8 degrees celsius range.However, it remains unclear whether frequent refrigerator door openings impacted the sr reagents stability.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ntbnp ii reagent lot 2150.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS SIGNAL 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24009234
• Report Number: 3007111389-2026-00001
• Device Sequence Number: 15781736
• Product Code: PPM
• UDI-Device Identifier: 10758750008360
• UDI-Public: (01)10758750008360(17)260226(11)250902(10)2482
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/08/2026

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: 02/26/2026
• Device Catalogue Number: 1072693
• Device Lot Number: 2482
• 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: 12/12/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• 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