MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS XT 7600 INTEGRATED SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6844461
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that lower than expected nt-probnp ii (ntbnp ii) results were obtained when processing a non-vitros biorad liquichek cardiac marker plus lt quality control (qc) fluid lot 1003110 on a vitros xt 7600 integrated system.The assignable cause of the event was an instrument related issue.Review of the instruments mechanical performance identified microwell incubator shuttle-related error codes.Additionally, the luminometer irs signal dropped to zero on two occasions within the two-week review period.As part of troubleshooting, the customer performed weekly maintenance on the microwell subsystem.In addition, they cleaned the fiber optic bundle (fob) and completed an irs calibration per as required maintenance.The biorad qc results were acceptable following completion of these weekly and as required maintenance activities.A review of qc performance prior to the reported event confirmed that the vitros nt-probnp ii assay was performing as expected when compared to the laboratories qc mean and range.A subsequent review of nt-probnp ii qc results following maintenance activities confirmed that the non-vitros bio-rad liquichek cardiac marker plus lt qc result were performing as expected.Based on this data, a reagent-related issue was ruled out as a contributor to the event.In addition, continual track and complaint trending has not identified any signals indicating a potential systematic issue associated with vitros nt-probnp ii reagent lot 2140.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected nt-probnp ii (ntbnp ii) results were obtained when processing a non-vitros biorad liquichek cardiac marker plus lt quality control (qc) fluid lot 1003110 on a vitros xt 7600 integrated system.Biorad level 2 results of 10.93, 11.07, 11.30 and 12.87 pmol/l vs expected result of 17.3 pmol/l 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 results were obtained when processing non-vitros qc fluid.There were no reported allegations of patient 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).

• Brand Name: VITROS XT 7600 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: 24272105
• Report Number: 1319681-2026-00004
• Device Sequence Number: 16133061
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 02/04/2026

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 Catalogue Number: 6844461
• 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: 01/08/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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