MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC ROCHESTER VITROS IMMUNODIAGNOSTIC PRODUCTS SIGNAL REAGENT; IN VITROS 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	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a lower than expected vitros ntbnp ii result was obtained when processing a non-vitros qualab biotech quality control (qc) fluid lot 2510a05423 on a vitros 5600 integrated system.The assignable cause of the event was an issue related to the vitros signal reagent (sr) pack in use at the time of the event.The investigation found that a newly replaced signal reagent had been stored in an area that did not have the correct temperature settings.Temperature monitoring revealed storage conditions exceeded 9 degrees celsius, reaching 10 degrees celsius inside the reagent kit, which likely compromised reagent stability and caused the lower than expected vitros ntbnp ii qc result.According to the vitros signal reagent instructions for use, the packs should be stored at 2 - 8 degrees celsius.It was concluded that the elevated storage temperature likely affected the stability of the signal reagent, resulting in low quality control results.The suspect vitros signal reagent pack was replaced and assay results returned to expectations.The rest of the vitros signal reagent was relocated to a more temperature-stable area, and ongoing monitoring was implemented.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ntbnp ii reagent lot 2080.
Event or Problem Description
The investigation has determined that a lower-than-expected nt probnp ii (ntbnp ii) result was obtained when processing a non-vitros qualab biotech quality control (qc) fluid lot 2510a05423 on a vitros 5600 integrated system.Biotech lot 2510a05423 = 159.0 pg/ml versus the expected result of 352.67 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower-than-expected vitros ntbnp ii result was obtained from a non-patient quality control fluid.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There were no allegations of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS SIGNAL REAGENT
• Common Device Name: IN VITROS DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC ROCHESTER; 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: 23848556
• Report Number: 3007111389-2025-00137
• Device Sequence Number: 18600747
• Product Code: PPM
• UDI-Device Identifier: 10758750008360
• UDI-Public: (01)10758750008360(17)251231(11)250702(10)2427
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: 12/31/2025
• Device Catalogue Number: 1072693
• Device Lot Number: 2427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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