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

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	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected nt - probnp ii (nbnp2) results were obtained from vitros nbnp2 lot 0660 when processing a non-vitros biorad liquichek cardiac marker plus lt quality control (qc) fluid lot 67710 on a vitros xt 7600 integrated system.The assignable cause of the event was an instrument related issue.It was verified that 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 low nbnp2 biorad qc results were obtained.The vitros nbnp2 assay is highly sensitive to well wash temperature and incubator temperature.An ortho fe went to the customer site and performed the following actions: identified and repaired a leak within the auxiliary wash bottle and replaced the inner and middle ring motor and replaced the incubator gaskets within the microwell incubator.In addition, the ortho fe replaced the microimmunoassay (uia) metering zee guide to improve uia metering function.Acceptable results for vitros nbnp2 were obtained following the service actions performed by the ortho fe, indicating that the low qc results were due to an issue with the vitros xt7600 system.Continual tracking and trending does not indicate a systemic issue with vitros nbnp2 lot 0660.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected nt - probnp ii (nbnp2) results obtained from vitros nbnp2 lot 0660 when processing a non-vitros biorad liquichek cardiac marker plus lt quality control (qc) fluid lot 67710 on a vitros xt 7600 integrated system.Biorad l2 vitros nbnp results of 124.0 and 146.1 pg/ml vs expected result of 195.1 pg/ml.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 nbnp2 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: CLINICAL CHEMISTRY
• 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: 24802146
• Report Number: 1319681-2026-00022
• Device Sequence Number: 13431600
• 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): 04/07/2026

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: 03/13/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2020
• 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