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

Catalog Number	6844461
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	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher and lower than expected vitros ammonia (amon) results obtained from a non-vitros mas quality control fluid processed using vitros chemistry products amon slides lot 1019-0266-5792 on a vitros xt 7600 integrated system.Mas control lot aa2604 l2 vitros amon results of 115.8, 108.7, 119.0, 82.1, 108.2, 115.4, 104.2, 113.3, 117.0, 110.7, 111.0, 112.2, 112.4, 90.9, 181.6, 180.2, 180.1, 180.2, 182.4, 179.6, 182.5, 180.8, 182.3, 180.6, 212.3, 195.8, 191.7, 182.8, 181.8, 186.3, 182.7, 179.6, 180.7, 181.9, 179.3, 180.4 and 182.2 umol/l versus an expected result of 149.0 umol/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 higher and lower than expected vitros amon results were obtained when processing a control fluid.The customer stated that no patient sample results have been questioned by physicians.However, the investigation cannot conclude that patient sample results were not or would not be affected if the event were to recur undetected.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) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that higher and lower than expected vitros ammonia (amon) results were obtained from a non-vitros mas quality control fluid processed using vitros chemistry products amon slides lot 1019-0266-5792 on a vitros xt 7600 integrated system.The assignable cause of the event is an instrument issue likely related to microslide incubator contamination.Quality control results for the vitros amon reagent were not within expectations and the results of within run precision testing processed on the vitros xt 7600 system were not acceptable.The customer performed the microslide incubator decontamination procedure on the vitros xt 7600 system.Additionally, the customer replaced the pm ring evaporation caps as well as the reflectance pads.Following the maintenance actions and a recalibration event, quality control results using the mas control fluids have returned to expectations.

• 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: 24533569
• Report Number: 1319681-2026-00011
• Device Sequence Number: 8972109
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2021
• 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