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); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report that non-reproducible, higher than expected vitros glucose (glu) results were obtained from eight different patient samples tested on a vitros 4600 chemistry system.Patient sample 1: vitros glu result of 18.95 mmol/l vs.The repeat result of 5.8 mmol/l patient sample 2: vitros glu result of 19.06 mmol/l vs.The repeat result of 7.4 mmol/l patient sample 3: vitros glu result of 19.17 mmol/l vs.The repeat result of 7.8 mmol/l patient sample 4: vitros glu result of 19.07 mmol/l vs.The repeat result of 5.8 mmol/l patient sample 6: vitros glu result of 18.73 mmol/l vs.The repeat result of 6.1 mmol/l patient sample 7: vitros glu result of 19.03 mmol/l vs.The repeat result of 6.2 mmol/l patient sample 8: vitros glu result of 18.95 mmol/l vs.The repeat result of 5.8 mmol/l patient sample 9: vitros glu result of 18.92 mmol/l vs.The repeat result of 5.4 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.All eight of the higher than expected vitros glu results were reported from the laboratory, however, corrected reports were issue and no treatment was stopped, started or altered based on the higher than expected results.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 non-reproducible, higher than expected vitros glucose (glu) results were obtained from eight different patient samples tested on a vitros 4600 chemistry system.The assignable cause of the event is user error.The vitros operator manually loaded a vitros prot cartridge into slide supply but manually identified the vitros prot cartridge as a vitros glu slide lot 0048-3255-2107 cartridge.Vdocs (onboard documentation) has this precaution for manual slide cartridge loading: warning: during the manual load process, once you open the slide supply door, you must place the cartridge that you have identified in the "manually load cart" dialog into the presented slide supply slot.Failure to do so may result in tests being performed with slides from an incorrect cartridge, potentially leading to wrong patient results.

• 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: 23876590
• Report Number: 1319681-2025-00060
• Device Sequence Number: 17336143
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: (01)10758750012343
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/22/2025

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: 12/10/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2018
• 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