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

Catalog Number	6844295
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a higher than expected glucose (glu) result was obtained from a single patient sample using vitros chemistry products glu slides lot 7426-0023-0184 on a vitros xt 7600 integrated system.A definitive assignable cause of the event could not be determined.Based on historical quality control results, a vitros glu lot 7426-0023-0184 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.The results of vitros alkp precision testing performed on the vitros xt 7600 integrated system were within ortho acceptable guidelines.In addition, the expected (repeat) result was observed by the customer without any change to the vitros xt 7600 integrated system.Therefore, an instrument related issue is not a likely contributing factor of the event.Pre-analytical sample processing could not be ruled out as a contributing factor as the customer is not following the sample collection device manufacturers recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Pre-analytical sample mix-up was not a likely contributor to the event, as a review of the sample viscosities showed similar results between the initial and repeat samples, indicating that the same sample was processed.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher-than-expected glucose (glu) result was obtained from a single patient sample using vitros chemistry products glu slides lot 7426-0023-0184 on a vitros xt 7600 integrated system.Patient sample result of 528.0 mg/dl vs the expected result of 78.0 mg/dl 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 glu result was not reported from the laboratory.The customer has confirmed that 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).

• Brand Name: VITROS XT CHEMISTRY PRODUCTS GLU-CA 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: 24682583
• Report Number: 1319809-2026-00026
• Device Sequence Number: 18645516
• Product Code: CGA
• UDI-Device Identifier: 10758750031795
• UDI-Public: (01)10758750031795(17)270501(11)251120(10)742600230184
• 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): 03/24/2026

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: 6844295
• Device Lot Number: 7426-0023-0184
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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