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

Catalog Number	6802445
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	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher and lower than expected vitros ammonia (amon) results were obtained from non-vitros biorad quality control fluids processed using vitros chemistry products amon slides lot 1020-0267-8992 on a vitros 4600 chemistry system.The assignable cause of the higher and lower than expected vitros amon results is an instrument issue related to microslide incubator contamination.Vitros amon lot 1020-0267-8992 results from the biorad control fluids were imprecise.An ortho field engineer (fe) performed service actions on the vitros 4600 system which included the following: - clean the cm/rt hot plate - clean the discard and insert blades - remove and clean all surfaces of the cm/rt evaporation caps - clean the bottom of the cm/rt incubator disk - clean the incubator slots - clean the blade slots the ortho fe also verified the microslide proboscis was in good condition.Post service vitros amon lot 1020-0267-8992 quality control results were within expectation, indicating that the ortho fe actions above resolved the issue.
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 were obtained from non-vitros biorad quality control fluids processed using vitros chemistry products amon slides lot 1020-0267-8992 on a vitros 4600 chemistry system.Biorad level 2 lot 54430 results of 162.3, 162.8, 158.4, 63.2, 67.7, 67.9 umol/l versus the expected result of 92.0 umol/l biorad level 3 lot 54430 results of 168.7, 170.5 umol/l versus the expected result of 240.0 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 control fluids.No results were reported out of the laboratory.There have been 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 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 23003720
• Report Number: 1319681-2025-00042
• Device Sequence Number: 9619413
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: (01)10758750012343
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/08/2025

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: 08/12/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2016
• 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