MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 4600 CHEMISTRY SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6802445
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concluded that higher than expected results were obtained from two different levels of non-vitros biorad ethanol/ammonia controls, lot: 54470, using vitros ammonia (amon) slide lot: 1023-0271-0768 on a vitros 4600 chemistry system.The investigation concluded the assignable cause of the event was an instrument related performance issue associated with microslide incubator contamination.After an ortho field engineer cleaned the microslide incubator, replaced the microslide evaporation caps and performed all necessary adjustments, acceptable vitros amon precision was obtained.
Event or Problem Description
The investigation concluded that higher than expected results were obtained from two different levels of non-vitros biorad ethanol/ammonia controls, lot: 54470, using vitros ammonia (amon) slide lot: 1023-0271-0768 on a vitros 4600 chemistry system.Biorad level 1 vitros amon results of 146.5 and 320.3 umol/l vs.The expected result of 27.5 umol/l biorad level 3 results of 288.1, 493.5, 283.7 and 299.0 umol/l vs.The expected result of 236.0 umol/l the higher-than-expected results were obtained from non-patient quality control fluids.There was no report of affected patient results and there was no allegation of patient harm.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).

• Brand Name: VITROS 4600 CHEMISTRY 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: 24574460
• Report Number: 1319681-2026-00014
• Device Sequence Number: 9234051
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: (01)10758750012343
• 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): 03/10/2026

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: 6802445
• 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: 02/11/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2017
• 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