MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 5600 INTEGRATED SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6802413
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that higher than expected sodium (na+) results were obtained from a vitros performance verifier using vitros chemistry products na+ slides lot: 4267-1147-8163 and lot: 4254-1134-2446 on a vitros 5600 integrated system.The assignable cause of the event is an instrument issue related to the performance of the vitros 5600 integrated system.Historical quality control results were imprecise and the results of a vitros na+ diagnostic precision test were not within ortho acceptable guidelines.An ortho field engineer performed service actions on the vitros 5600 system that included lubrication of the erf metering pump and replacement of the humidification pad.Post service vitros na+ results have been within expectations and there has been no reported recurrence from the customer of unacceptable vitros na+ results since the service actions were performed on the vitros 5600 system.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected sodium (na+) results were obtained from a vitros performance verifier using vitros chemistry products na+ slides lot: 4267-1147-8163 and lot: 4254-1134-2446 on a vitros 5600 integrated system.Vitros na+ lot: 4267-1147-8163: vitros pv i lot: v1665 results of 152.2, 148.3, 145.5, 140.6, >250.0, >250.0, >250.0, 201.4, 200.0, 199.7, 198.8, 198.5, 198.3, 197.6, 197.2, 197.0, 196.0, 194.7, 193.9, 140.1, 140.0, 139.8, 139.5, 139.5, 138.8, 138.6, 138.5, 138.1, 137.3 and 137.0 mmol/l vs an expected result of 115.4 mmol/l vitros na+ lot: 4254-1134-2446: vitros pv i lot: v1665 result of 138.9 mmol/l vs an expected result of 115.4 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 a quality control fluid and were not reported from the laboratory.There has been no reported allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers: (b)(4).

• Brand Name: VITROS 5600 INTEGRATED 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: 21309110
• Report Number: 1319681-2025-00006
• Device Sequence Number: 8883974
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: (01)10758750002740
• 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): 02/04/2025

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: 6802413
• 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: 01/08/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2012
• 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