MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS GLU SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number	1707801
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report multiple lower than expected vitros glucose (glu) results were obtained from a single patient sample tested on a vitros xt 3400 chemistry system.Patient sample results of 43.2, <20.0, 60.9, <20.0 and <20.0 mg/dl vs.The expected result of 300 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower-than-expected vitros glu results of were not reported outside of the laboratory and 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).
Additional Manufacturer Narrative
The investigation determined that multiple lower than expected vitros glucose (glu) results were obtained from a single patient sample tested on a vitros xt 3400 chemistry system.The assignable cause of the event could not be determined.An unknown sample interferent that affects the vitros glu assay but not the non-vitros glucose method cannot be ruled out as contributing to the event.Historic non-vitros thermofisher mas quality control results within the timeframe of the event indicated vitros glu slide lot 0048-3255-1946 was performing as intended on the vitros xt 3400 chemistry system and did not likely contribute to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros glu slide lot 0048-3255-1946.There was no indication the vitros xt 3400 chemistry system malfunctioned, however, no vitros diagnostic within-run precision testing, which is used to assess analyzer performance, was performed.Therefore, an instrument related performance issue cannot be completely ruled out as contributing to the event.However, since the issue was isolated to a single patient sample and since quality control results were acceptable, an instrument related performance issue did not likely contribute to the event.The customer did not provide any details concerning pre-analytical sample handling or preparation, however, since the vitros glu results were reproducibly lower than expected, a sample handling issue did not likely contribute to the event.

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU SLIDES
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 23585521
• Report Number: 1319809-2025-00092
• Device Sequence Number: 9305117
• Product Code: CGA
• UDI-Device Identifier: 10758750009572
• UDI-Public: (01)10758750009572(17)260901(11)250310(10)004832551946
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 11/18/2025

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 Expiration Date: 09/01/2026
• Device Catalogue Number: 1707801
• Device Lot Number: 0048-3255-1946
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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