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

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	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected digoxin (dgxn) results obtained from two different patient samples processed using vitros chemistry products dgxn slides lot 1939-0277-3072 on a vitros 5600 integrated system.Patient 1 vitros dgxn result of 1.74 nmol/l vs the expected result of < 0.51 nmol/l patient 2 vitros dgxn result of 2.04 nmol/l vs the expected result of 0.57 nmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher-than-expected vitros dgxn results were obtained while processing patient samples.No results were reported outside of the laboratory.There has been 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 higher than expected digoxin (dgxn) results were obtained from two different patient samples processed using vitros chemistry products dgxn slides lot 1939-0277-3072 on a vitros 5600 integrated system.The assignable cause of the event is an instrument related performance issue.Historical quality control results on j56000409 (j1) were accurate but imprecise in the two weeks leading up to the event.Biorad qc data from the customer other vitros 5600 integrated system (j56000492 (j2)) were both accurate and precise during the same timeframe.This data illustrates a performance issue specific to j1, as the same vitros dgxn slide lot 1939-0277-3072 and the same biorad qc fluids were utilized on both systems during this timeframe.In addition, an ortho service engineer (se) reviewed econnectivity for the affected j1 on (b)(6) 2026 and observed that the immuno wash fluid (iwf) metering shuttle zee adjustments were lower compared to historical trends on this analyzer around (b)(6) 2026, which may have contributed to the unexpected vitros dgxn qc values around the date of the event.A service order (so) has been created for an ortho field engineer (fe) to address the affected vitros 5600 integrated system (j1).

• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 25501046
• Report Number: 1319681-2026-00042
• Device Sequence Number: 10491950
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: (01)10758750002740
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/12/2026

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: 05/20/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2009
• 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