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

Catalog Number	6802413
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concludes that lower and higher than expected results were obtained from two different levels of vitros liquid performance verifier (lpv) fluids using vitros amon slide lot 1020-0267-8941 on a vitros 5600 integrated system.The assignable cause of the event is an instrument event related to microslide incubator ammonia contamination.The cause of the ammonia contamination was not determined.Results of precision testing demonstrated that the vitros 5600 integrated system was not operating as expected at the time of the event.Acceptable performance was obtained after the customer performed the maintenance procedures of performing the microslide incubator decontamination procedure and cleaning the microslide incubator evaporation caps and processing correction factor slides and making updates.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower and higher than expected results were obtained from two different levels of vitros liquid performance verifier (lpv) fluids using vitros amon slide lot 1020-0267-8941 on a vitros 5600 integrated system.Vitros lpv i lot j2575 results of 190.1, 169.5, 111.0 and 188.4 umol/l vs.The expected result of 47.5 umol/l vitros lpv ii lot k2576 results of 144.5, 135.9, 148.0, 249.9, 272.7, 159.6 and 150.4 umol/l vs.The expected result of 200.0 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.There was no report of affected patient results and there was no allegation of patient harm.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (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: 21761160
• Report Number: 1319681-2025-00017
• Device Sequence Number: 15622362
• 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): 04/01/2025

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: 03/06/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2018
• 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