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

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	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has concluded that lower than expected vitros hba1c reagent lot 1539-45-3183 results were obtained from american proficiency institute (api) proficiency samples and a level 2 vitros %a1c performance verifier (pv) fluid on a vitros 5600 integrated system.The assignable cause of the event is an issue with the vitros 5600 integrated system.Historical vitros hba1c lot 1539-45-3183 results were low outside the vitros assay sheet range of means but showed acceptable precision.Additionally, the vitros hba1c api sample results were lower than expected when tested using two different sets of api samples.When vitros hba1c lot 1539-45-3183 became depleted, the customer calibrated new vitros hba1c lot 2539-48-3640, and although the pv results were within expectation the api proficiency samples were still outside expectation.As unexpected results were obtained across two lots of vitros hba1c, an issue isolated to the reagent in use is not a likely contributor to the event.It was observed that the unexpected vitros hba1c results were obtained across multiple vitros hba1c reagent packs, however several the same reagent packs also produced acceptable results when processing the vitros pv fluids.Therefore, an issue isolated to the reagent packs in use is not a likely contributor to the events.An ortho field engineer (fe) went to the customer site and performed service actions that included replacing the uia metering proboscis (was not optimal and showing signs of wear) and performing a water blank.The customer then calibrated vitros hba1c and pv results were within expectation.The service actions performed by the ortho fe returned the vitros 5600 integrated system back to expected performance.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros hba1c reagent lot 1539-45-3183 results were obtained from american proficiency institute (api) proficiency samples and a level 2 vitros %a1c performance verifier (pv) fluid on a vitros 5600 integrated system.Api sample gly02 vitros hba1c results of 7.9, 8.23, 8.07, 8.28 %a1c vs the expected result of 9.6 %a1c api sample gly03 vitros hba1c results of 7.1, 7.31, 7.28 %a1c vs the expected result of 8.35 %a1c vitros %a1c pv ii, lot x2393 vitros hba1c results of 7.99, 8.04, 8.08, 8.04, 8.11, 7.91, 8.14, 8.08, 8.13, 8.09, 8.18 % a1c vs.The baseline mean of 9.16 %a1c.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros hba1c results were obtained from non-patient proficiency and quality control fluids.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: 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24904034
• Report Number: 1319681-2026-00026
• Device Sequence Number: 9102810
• 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): 04/16/2026

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: 03/19/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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