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

Catalog Number	6844294
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a discordant, higher than expected vitros creatinine (crea) result was obtained from a single patient sample processed using vitros xt chemistry products urea-crea slides lot: 7221-0020-2434 on a vitros xt 7600 integrated system.The result was discordant when compared to the result from the same sample using a non-vitros siemens atellica method.A definitive assignable cause of the event could not be determined.Based on historical quality control results a vitros xt urea-crea lot: 7221-0020-2434 related issue is not a likely contributing factor of the event.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros xt urea-crea reagent lot: 7221-0020-2434.As no precision testing was performed on the vitros xt 7600 integrated system an instrument related issue could not be completely ruled out as a contributor of the event.However, historical qc results were within expectations indicating that an instrument related issue was not a likely contributing factor of the event.In addition, 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.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.No information about the patient's condition or any medications or supplements being taken by the patient were provided upon request.Therefore, an interferent that affects the vitros method and not the non-vitros method cannot be confirmed or ruled out as a contributor of the event.Per a medical consult with an ortho medical safety officer on 17 november 2025: a patient's management may differ depending on their clinical history.If the patient had some degree of renal impairment, they may have persistently elevated crea above the normal reference range.Thus, both crea levels may not have similar clinical interpretation since a result of 2.21 mg/dl may represent an acute on chronic renal failure, while a baseline of 1.42 mg/dl result would be considered a stable chronic renal failure.Patient management for both are different.However, considering that the patient's treatment was not altered, no serious patient injury is expected.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant, higher than expected vitros creatinine (crea) result was obtained from a single patient sample processed using vitros xt chemistry products urea-crea slides lot: 7221-0020-2434 on a vitros xt 7600 integrated system.The result was discordant when compared to the result from the same sample using a non-vitros siemens atellica method.Patient sample vitros crea result of 2.21 mg/dl vs an expected result of 1.42 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, higher than expected vitros crea result was not reported outside of the laboratory.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).

• Brand Name: VITROS XT CHEMISTRY PRODUCTS UREA-CREA 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: 23621867
• Report Number: 1319809-2025-00096
• Device Sequence Number: 9051633
• Product Code: JFY
• UDI-Device Identifier: 10758750031788
• UDI-Public: (01)10758750031788(17)260901(11)250325(10)722100202434
• 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): 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 Expiration Date: 09/01/2026
• Device Catalogue Number: 6844294
• Device Lot Number: 7221-0020-2434
• 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: 10/30/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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