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

Catalog Number	6802413
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected amon results were obtained from quality control fluids processed using vitros amon slide lot 1020-0267-1182 on a vitros 5600 integrated system.The assignable cause of the event was determined to be an instrument related issue likely due to contamination of the microslide incubator.Vitros amon within run precision testing was unacceptable and atypical within-lab vitros amon qc performance was observed.In addition, the following were identified as additional contributing factors 1 - the customer was using amon slide cartridges that had expired 2 - the customer had added a user adjustment to multiple amon results 3 - the customer does not run all levels of control on a routine basis to confirm amon performance.A distributor field engineer is scheduled to go on site to replace incubator evaporation caps and perform incubator decontamination.These service actions are expected to resolve this amon issue.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected amon results were obtained from quality control fluids processed using vitros amon slide lot 1020-0267-1182 on a vitros 5600 integrated system.Amon l2 m2779 = 158.9, 143.1, 143.8, 150.3 versus expected 199.7 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.The customer reported that this amon issue was only with quality control results.However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.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).

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Common Device Name: CLINICAL CHEMISTRY
• 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: 22664537
• Report Number: 1319681-2025-00034
• Device Sequence Number: 12645669
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: (01)10758750002740(11)171003
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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): 07/29/2025

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: 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: 07/15/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2017
• 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