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

Catalog Number	6802584
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros crea result was obtained from a single patient sample processed using vitros chemistry products creatinine (crea) slides lot 1514-3574-2368 on a vitros 350 chemistry system.The result was higher than expected when compared to a non-vitros abbott architect method result obtained using the same sample.A definitive assignable cause could not be determined with the information provided.However, the most likely cause of the higher than expected vitros crea patient sample result is an interferent in the sample that affects the vitros crea method and not the non-vitros method.When the patient sample was initially processed without dilution, no result was obtained and a dp condition code displayed on the vitros instrument.According to the vitros crea instructions for use (ifu), if the analyzer displays a dp code, dilute the sample as a dp code indicates high background density.The high background density is usually due to an elevated creatine concentration.Creatine is a known interferent for the vitros crea assay.Additionally, at the time of the event, the patient was taking iron supplements and anxiety medication.According to the vitros crea ifu, certain drugs and clinical conditions are known to alter creatinine concentration in vivo.Historical quality control results for vitros crea lot 1514-3574-2368 were within expectations.Additionally, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros crea reagent lot 1514-3574-2368.No precision testing was performed on the vitros 350 system and therefore, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.However, there was no evidence of an instrument issue.Additionally, at the time of the event, the patient was taking iron supplements and anxiety medication.According to the vitros crea ifu, certain drugs and clinical conditions are known to alter creatinine concentration in vivo.Historical quality control results for vitros crea lot 1514-3574-2368 were within expectations.Additionally, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros crea reagent lot 1514-3574-2368.No precision testing was performed on the vitros 350 system and therefore, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.However, there was no evidence of an instrument issue.Additionally, 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 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.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher-than-expected vitros crea result obtained from a single patient sample processed using vitros chemistry products creatinine (crea) slides lot 1514-3574-2368 on a vitros 350 chemistry system.The result was higher than expected when compared to a non-vitros abbott architect method result obtained using the same sample.Patient sample vitros crea result of 142 umol/l (diluted) versus an expected result of 71 umol/l 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 crea result of 142 umol/l was reported outside of the laboratory.However, no treatment was initiated, altered or stopped based on the result.A corrected report of 71 umol/l 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 (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS 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: 24617219
• Report Number: 1319809-2026-00024
• Device Sequence Number: 15987014
• Product Code: JFY
• UDI-Device Identifier: 10758750002849
• UDI-Public: (01)10758750002849(17)260901(11)250322(10)151435742368
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/16/2026

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 Expiration Date: 09/01/2026
• Device Catalogue Number: 6802584
• Device Lot Number: 1514-3574-2368
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2025
• 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