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	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report quality control results shifted low on two levels of non-vitros eurobio quality control (qc) fluid using multiple vitros microwell assays.Although multiple microwell assays were affected, only results obtained from the vitros nbnp2, tsh3, and hstni assays met potential health and safety (phs) criteria.Vitros nbnp2 reagent (lot 2290): non-vitros eurobio (lot 2309898) level 1 result of 20.0 pg/ml vs.The expected result of 95.0 pg/ml non-vitros eurobio (lot 2309899) level 1 result of 25.3 pg/ml vs.The expected result of 1,635.0 pg/ml vitros tsh3 reagent (lot 1100): non-vitros eurobio (lot 2309898) level 1 result of 1.67 miu/l vs.The expected result of 2.62 miu/l non-vitros eurobio (lot 2309899) level 1 result of 2.57 miu/l vs.The expected result of 10.05 miu/l vitros hstni reagent (lot 1580): non-vitros eurobio (lot 2309898) level 1 result of 8.75 ng/l vs.The expected result of 77.40 ng/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.Patient samples were not affected and there was no allegation of 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).
Additional Manufacturer Narrative
The customer reported that quality control results shifted low on two levels of non-vitros eurobio quality control (qc) fluid using multiple vitros microwell assays.Although multiple microwell assays were affected, only results obtained from the vitros nbnp2, tsh3, and hstni assays met potential health and safety (phs) criteria.The investigation concluded that the cause of the event was an instrument related issue.Multiple vitros microwell assays were affected, and expected performance was obtained after an ortho service event where an ortho field application specialist (fas) performed an adjustment on the microwell incubator shuttle followed by an incubator reference system (irs) calibration event.Since the issue was resolved by actions performed by the ortho fas on the vitros xt 7600 integrated system, this indicates a performance issue with the vitros xt 7600 integrated system was the assignable cause of the event.

• 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: 25280738
• Report Number: 1319681-2026-00032
• Device Sequence Number: 10085528
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/26/2026

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: 04/29/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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