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	04/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concludes that lower than expected results were obtained from a single level of non-vitros biorad ethanol/ammonia controls, lot 54480 using vitros amon slide lot 1023-0271-2293 on a vitros 5600 integrated system.The assignable cause of the event is an instrument event related to microslide incubator.It is likely that ammonia contamination was present in the microslide incubator, however, no pre-service vitros amon within-run precision test was performed, therefore, ammonia contamination in the microslide incubator could not be confirmed.A vitros field engineer (fe) went on site and replaced the cm/rt evaporation caps and cleaned the microslide incubator.Post-service vitros amon results were reviewed for the timeframe of 01 may 2026 through 18 may 2026, and acceptable vitros amon performance was obtained.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected results obtained from a single level of non-vitros biorad ethanol/ammonia controls, lot 54480 using vitros amon slide lot 1023-0271-2293 on a vitros 5600 integrated system.Biorad l2 vitros amon results of 120.5 and 109.6 umol/l vs.The expected result of 90.91 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 non-reproducible vitros amon results were obtained from a non-patient quality control fluid and there was no allegation of patient harm.However, the investigation cannot conclude that patient sample results had not been affected or would not be affected if the event were to recur undetected.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 25284283
• Report Number: 1319681-2026-00034
• Device Sequence Number: 13285420
• 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): 05/26/2026

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: 04/29/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2018
• 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