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

Catalog Number	6844294
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	07/23/2025
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 vitros creatinine (crea) result was obtained from a single patient sample processed using vitros xt chemistry products urea-crea slides lot 7222-0021-3935 on a vitros xt 7600 integrated system.Patient sample vitros crea result of <0.25 mg/dl vs an expected result of 4.96 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, lower than expected vitros crea result was reported outside of the laboratory.However, a physician questioned the result, and no treatment was initiated, altered or stopped based on the result.A corrected report was later issued for the patient.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 611632.
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, lower than expected vitros crea result was obtained from a single patient sample processed using vitros xt chemistry products urea-crea slides lot 7222-0021-3935 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 xt urea-crea lot 7222-0021-3935 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 7222-0021-3935.However, an individual slide related issue could not be entirely ruled out.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 precise indicating that an instrument related issue was not a likely contributing factor of the event.Additionally, an acceptable vitros crea result was later obtained from the initial patient sample without any known actions being performed on the instrument.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturer 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.

• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 22806684
• Report Number: 1319809-2025-00072
• Device Sequence Number: 8960209
• Product Code: JFY
• UDI-Device Identifier: 10758750031788
• UDI-Public: (01)10758750031788(17)261101(11)250512(10)722200213935
• 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): 08/13/2025

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: 7222-0021-3935
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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