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

Catalog Number	6272222
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower and higher than expected results were obtained from multiple qc fluids and a single patient sample using vitros ckmb2 lot: 0201 and vitros nbnp2, lot: 0690 on a vitros xt 7600 integrated system.The assignable cause of the event is an instrument related issue.It was verified that a condition code related to the well wash heater for higher-than-expected temperatures were obtained on the vitros xt7600 system during the time when the unexpected nbnp2 and ckmb2 mas qc results were obtained.The vitros nbnp2 and ckmb2 assays are highly sensitive to well wash temperature.Additionally, it was determined that the customer was not cleaning the microwell incubator properly and the microwell incubator cover was not opened for the appropriate amount of time to complete sufficient cleaning.An ortho field engineer (fe) went to the customer site and performed actions including adjustments, maintenance and performance testing, and calibrating the luminometer and the irs.Acceptable qc results for vitros nbnp2 and ckmb2 were obtained following the service actions performed by the ortho fe, however the customer again experienced unexpected results during a post-service vitros nbnp2 precision test.The ortho fe continues to work with the tsc and ortho service engineer (se) on additional actions to perform on the vitros xt7600 system.It is expected that further fe actions will return the vitros xt7600 system to expected performance.Continual tracking and trending did not indicate a systemic issue with vitros nbnp2 lot: 0690 and vitros ckmb2 lot: 0201.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower-than-expected creatinine kinase mb (ckmb) result was obtained from one level of mas cardioimmune xl quality control (qc) fluid lot: cxl2704 using vitros ckmb2, lot: 0201.In addition, higher and lower than expected nt-probnp ii (nbnp2) results were obtained from vitros nbnp2 lot: 0690 when processing two levels of mas qc fluids, a single patient sample, and two levels of vitros nbnp2 qc fluids on a vitros xt 7600 integrated system.Vitros ckmb2 mas level 2 result of 2.59 ng/ml versus the expected result of 3.46 ng/ml vitros nbnp2 mas level 1 result of 250.45 pg/ml versus the expected result of 345.0 pg/ml vitros nbnp2 mas level 2 results of 1143.04, 1253.45, 1265.95, 1103.69 pg/ml versus the expected result of 1753.0 pg/ml vitros nbnp2 patient result of 836.78 pg/ml versus the expected result of 1153.46 pg/ml vitros nbnp2 level 1 vitros nbnp2 qc result of 163.26 pg/ml versus the expected result of 98.0 pg/ml vitros nbnp2 level 2 vitros nbnp2 qc result of 1507.45, 652.57, 607.15, 721.43, 633.71 pg/ml versus the expected result of 998.0 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher and lower than expected vitros nbnp2 results were obtained when processing quality control fluids.In addition, a patient sample was processed for troubleshooting purposes.There were no allegations 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: 25233230
• Report Number: 1319681-2026-00033
• Device Sequence Number: 5239472
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 6272222
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown