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

Catalog Number	6802445
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report that demographics for a patient (b) were mis-associated with the results obtained from a sample tube from a different patient (a) when samples were processed on a vitros 4600 chemistry system.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The customer stated that the discrepant patient sample results were reported out of the laboratory.However, a physician questioned the results and repeat testing occurred.No treatment was initiated, altered or stopped based on the results.There was no allegation of patient harm related to this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).
Additional Manufacturer Narrative
The investigation determined that demographics for a patient (b) were mis-associated with the results obtained from a sample tube from a different patient (b)(6) when samples were processed on a vitros 4600 chemistry system.The likely cause of the event is pre-analytical operator error when labeling the patient samples.The ortho tsc reviewed e-connectivity data as well as vitros laboratory computer interface (lci) files.According to the data review, the tray movements, potential error reactions and condition codes do not show any indications of abnormality or an analyzer issue.The analyzer movements and metering event were as expected.The sample patient a results were from a sample in a tray that only had one sample placed in tray 20, cup 1.This matches lci files and patient report results.There were no indications that the vitros 4600 chemistry system malfunctioned.

• 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: 21929418
• Report Number: 1319681-2025-00022
• Device Sequence Number: 18397653
• 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): 04/29/2025

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: 04/02/2025
• Initial Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2012
• 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