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

Catalog Number	6802445
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected, non-reproducible vitros na+ results were obtained from a single non-vitros biorad multiqual unassayed control, lot: 56760 fluid and a single vitros performance verifier (pv) i, lot: e2828 fluid using vitros na+ slide lot: 4206-1179- 8305 on a vitros 4600 chemistry system.The assignable cause of the event is an instrument performance issue.A diagnostic vitros na+ within-run precision test was outside of the acceptance criteria indicating a performance issue with the potentiometric subsystem of the vitros 4600 chemistry system.The customer replaced the evaporation caps of the microslide pm incubator, however, did not repeat a diagnostic vitros na+ within-run precision test to assess the performance of the pm subsystem after replacing the pm evaporation caps.Historical quality control results indicated there is slight imprecision observed using the biorad l1 control since the pm evaporation caps were replaced.An ortho field engineer will be sent on site to investigate the performance of the potentiometric subsystem of the vitros 4600 chemistry system.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected, non-reproducible vitros na+ results obtained from a single non-vitros biorad multiqual unassayed control, lot 56760 fluid and a single vitros performance verifier (pv) i, lot: e2828 fluid using vitros chemistry products sodium (na+) slide lot: 4206-1179- 8305 on a vitros 4600 chemistry system.Biorad l1 vitros na+ result of >250 mmol/l vs.The expected baseline mean result of 109.8 mmol/l vitros pv i lot: e2828 vitros na+ result of >250 mmol/l vs.The expected range of means midpoint value of 125.8 mmol/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-than-expected vitros na+ results were obtained from non-patient quality control fluid, however, patient sample results were also affected but the results were not reported outside of the laboratory.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).

• Brand Name: VITROS 4600 CHEMISTRY 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: 24778105
• Report Number: 1319681-2026-00020
• Device Sequence Number: 9987858
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: (01)10758750012343
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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: 03/12/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2012
• 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