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

Catalog Number	1707801
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, lower than expected glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu slides lot 0002-3259-4363 on a vitros 5600 integrated system.Patient sample result of 42.1 mg/dl vs an expected results of 282.2 and 276.8 mg/dl biased results of the magnitude and direction observed may led to inappropriate physician action if they were to occur undetected.The lower-than-expected vitros glu result was not reported from the laboratory.There have been no reported allegations 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 a non-reproducible, lower than expected glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu slides lot 0002-3259-4363 on a vitros 5600 integrated system.A definitive assignable cause of the event could not be determined.Based on acceptable historical quality control results, a vitros glu lot 0002-3259-4363 performance issue is not likely a contributor to the event.However, an individual slide related issue cannot be entirely ruled out as a contributing factor.Additionally, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros glu reagent lot 0002-3259-4363.There was no indication that the vitros 5600 system malfunctioned.A diagnostic vitros glu precision test was within ortho acceptable guidelines, indicating that vitros glu lot 0002-3259-4363 was performing as expected in combination with the vitros 5600 system.Pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturer's recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event although this could not be confirmed.A review of the pressure profiles of the individual patient sample runs confirmed that there was no indication that a pre-analytical patient sample mix-up occurred.

• 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: 23618636
• Report Number: 1319809-2025-00095
• Device Sequence Number: 10037848
• Product Code: CGA
• UDI-Device Identifier: 10758750009572
• UDI-Public: (01)10758750009572(17)261101(11)250524(10)000232594363
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/21/2025

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: 1707801
• Device Lot Number: 0002-3259-4363
• 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: 11/04/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2025
• 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