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	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that higher than expected results were obtained from a non-vitros biorad quality control using vitros chemistry products potassium (k+) slides lot: 4102-1201-0548 processed on a vitros 4600 chemistry system.The assignable cause of the higher-than-expected vitros k+ results is suboptimal calibrations.The parameters for the calibrations used at the time of the event were determined to be suboptimal compared to the database values.The cause of the suboptimal calibrations is user error as the customer was using vitros calibrator kit 32 fluids while programming the calibrations on the instrument for vitros calibrator kit 2.Following a recalibration event using vitros cal kit 32 fluids and correctly programming the instrument for kit 32, post calibration results returned to expectations.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected results were obtained from a non-vitros biorad quality control using vitros chemistry products potassium (k+) slides lot: 4102-1201-0548 processed on a vitros 4600 chemistry system.Biorad lot: 46030 level 1 results of 3.75, 3.78, 3.79, 3.85, 3.77 and 3.79 mmol/l vs an expected result of 2.57 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 results were obtained from quality control fluids and no results were reported from the laboratory.Patient samples were affected, however, none of the patient sample results breached potential health and safety criteria and the results were not reported from the laboratory.There have been no allegations 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: 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: 24809295
• Report Number: 1319681-2026-00023
• Device Sequence Number: 21503474
• 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): 04/07/2026

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: 03/11/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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