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	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros creatinine xt (creaxt) results were obtained from a single patient sample.The results were considered higher than expected when compared to the vitros creaxt result obtained from a second sample collected from the same patient.Vitros crea patient sample 1 results of 2.17 and 1.85 mg/dl vs sample 2 vitros creaxt result of 0.91 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 creaxt result of 2.17 mg/dl was reported from the laboratory, however, no treatment was stopped, started or altered.The higher-than-expected vitros creaxt result of 1.85 mg/dl was not reported from the laboratory.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
A customer contacted ortho to report higher than expected vitros creatinine xt (creaxt) results were obtained from a single patient sample.The results were considered higher than expected when compared to the vitros creaxt result obtained from a second sample collected from the same patient.The assignable cause of the event was a sample related issue.No vitros creaxt results were obtained from sample 1 due to substrate depletion, and concordant results above the vitros creaxt reference interval for both men and woman were obtained after retesting sample 1 with 5x and 2x dilutions.It is unknown why sample 2 did not have a substrate depletion issue.The ortho tsc requested the customer provide a list of medications and a diagnosis for the affected patient, however, the customer has not provided information for either of these requests.Pre-analytical sample mix-up did not likely occur as the vitros microslide results obtained from both sample 1 and sample 2 were concordant, indicating both samples were likely collected from the same patient.Historic biorad quality control results prior to, and within the timeframe of the event indicated vitros creaxt slide lot 7222-0021-6233 was performing as intended on the vitros xt7600 integrated system and did not likely contributed 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 creaxt slide lot 7222-0021-6233.There was no indication the vitros xt7600 integrated system was not performing as intended, however, no vitros diagnostic within-run precision testing 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.

• 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: 23310069
• Report Number: 1319809-2025-00082
• Device Sequence Number: 12045898
• Product Code: JFY
• UDI-Device Identifier: 10758750031788
• UDI-Public: (01)10758750031788(17)270101(11)250722(10)722200216233
• Combination Product (Y/N): N
• 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): 10/16/2025

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: 6844294
• Device Lot Number: 7222-0021-6233
• 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: 09/17/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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