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

Catalog Number	6844461
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros sodium (na+) results were obtained from a single level of non-vitros thermofisher mas omnicore control, lot: ocr2608, tested on a vitros xt 7600 integrated system.The vitros na+ results were higher than expected when compared to the expected established targets for those mas controls.The most likely assignable cause of the event is an instrument related performance issue.Diagnostic vitros na+ within-run precision testing was not completed due to instrument condition codes.The customer performed an auto-centering adjustment and acceptable vitros na+ precision results were obtained following the adjustment.Historical mas quality control results were also unacceptable within the timeframe of the event, which exhibited within-lab imprecision.This within-lab imprecision was likely caused by the instrument related performance issue resolved by the auto-centering adjustment.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros sodium (na+) results were obtained from a single level of non-vitros thermofisher mas omnicore control, lot: ocr2608, tested on a vitros xt 7600 integrated system.The vitros na+ results were higher than expected when compared to the expected established target for the mas controls.Vitros na+ slide lot: 4287-1167-4622 mas level 1 na+ results of 146.2, 146.9 and 136.9 mmol/l vs.The expected result of 120.33 mmol/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 vitros na+ results that met potential health and safety criteria were obtained from non-patient quality control samples.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (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: 24381056
• Report Number: 1319681-2026-00008
• Device Sequence Number: 10490617
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/18/2026

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: 01/21/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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