MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 5600 INTEGRATED SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6802413
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that discordant, lower than expected troponin i (hstni) and nt-probnp ii (nbnp2) results were obtained when processing quality control (qc) and patient samples tested using vitros hstni reagent lot 1340 and vitros nbnp2 lot 2080 on a vitros 5600 integrated system.The assignable cause of the event is an issue related to the mircrowell subsystem of the vitros 5600 system.The customer stated that the issue was resolved after loading a new signal reagent (sr) pack.Qc data was requested for vitros hstni lot 1340 and vitros nbnp2 lot 2080 but not provided by the customer.However, the customer stated that the qc results for these assays were lower than expected at the time of the event, and that after the sr pack was replaced the qc results returned to expectation.Therefore, a potential issue related to vitros hstni lot 1340 or vitros nbnp2 lot 2080 is not a likely contributor to the event.The customer did not perform a marker precision test on the vitros 5600 integrated system when requested.However, as the customer stated that after changing the sr pack that patient and qc results returned to expectation, the issue was likely analyzer related.Continual tracking and trending of complaint data has not identified any signals that would point to a potential systemic quality issue with vitros hstni reagent lot 1340 or vitros nbnp2 lot 2080.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, lower than expected troponin i (hstni) and nt-probnp ii (nbnp2) results were obtained when processing quality control (qc) and patient samples tested using vitros hstni reagent lot 1340 and vitros nbnp2 lot 2080 on a vitros 5600 integrated system.Vitros hstni: patient 4 vitros hstni result of 10.62 ng/l (below ami cutoff) versus the expected vitros hstni result of 31.81 ng/l (above ami cutoff) patient 5 vitros hstni result of 6.8 ng/l (below ami cutoff) versus the expected vitros hstni result of 20.17 ng/l (above ami cutoff) vitros nbnp2: patient 8 vitros nbnp2 result of 924.0 pmol/l versus the expected vitros nbnp2 result of 2540.0 pmol/l patient 9 vitros nbnp2 result of 937.0 pmol/l versus the expected vitros nbnp2 result of 2550.0 pmol/l patient 10 vitros nbnp2 result of 745.0 pmol/l versus the expected vitros nbnp2 result of 2000.0 pmol/l 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 hstni and vitros nbnp2 results were reported from the laboratory and corrected reports were later issued.No treatment was stopped, started or altered based on the lower-than-expected results.There was no allegation of patient harm as a result of these events.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Common Device Name: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 23727793
• Report Number: 1319681-2025-00058
• Device Sequence Number: 10231933
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: (01)10758750002740
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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 Catalogue Number: 6802413
• 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: 11/07/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• 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