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	08/06/2025
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 (crea) results were obtained from three different patient samples tested on a vitros xt 3400 chemistry system when compared to results obtained from processing different samples from the same collection from the same patients tested on a non-vitros beckman coulter au5800.Vitros crea slide lot 7219-0018-5809: patient sample 2 vitros crea results of 2.04 and 1.95 mg/dl vs.The expected result of 1.13 mg/dl.Vitros crea slide lot 7222-0021-3935: patient sample 3 vitros crea result of 1.60 mg/dl vs.The expected result of 0.95 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 crea results were not reported outside of the laboratory and there was no allegation of patient harm as a result of the event.This report is number two of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros creatinine (crea) results were obtained from three different patient samples tested on a vitros xt 3400 chemistry system when compared to results obtained from processing different samples from the same collection from the same patients tested on a non-vitros beckman coulter au5800.The assignable cause for the issue is creatine interference in the samples.The patients were confirmed to be taking creatine supplements.The concentration of creatine in the supplements nor the dosage were provided.Per the vitros crea instructions for use (ifu), limitations of the procedure, known interferences: creatine: at a creatinine concentration of 1.5 mg/dl (133 umol/l), creatine greater than 8 mg/dl (707 umol/l) will be flagged with a dp code (because highly elevated creatine concentrations may cause excessive background density).At a creatinine concentration of 14 mg/dl (1237 umol/l), creatine greater than 1 mg/dl (88 umol/l) will be flagged with a dp code.Refer to "sample dilution" for dilution instructions.The vitros xt 3400 chemistry system did not generate vitros crea results when the patient samples were tested undiluted due to the occurrence of either an "er" or "dp" sample code, which indicates computational error or substrate depletion, respectfully.The most likely cause of the er and dp sample codes is an interferent in the sample, such a creatine, which would be diluted out with the sample dilution prior to repeat testing.Per the vitros flags and codes on reports, the description for a dp sample code is substrate depletion, and the suggested action is to dilute the sample and repeat the test.The higher than expected vitros crea results were obtained from 2x dilutions of the sample.Historical quality control (qc) results were acceptable, indicating vitros crea slide lot 7219-0018-5809 did not likely contribute to the event.No historical qc results from vitros crea slide lot 7222-0021-3935 were provided; however, the customer confirmed that the only patient samples that were affected were from patients who were confirmed to be taking creatine supplements.Therefore, although vitros crea slide lot 7222-0021-3935 performance could not be confirmed, no other patient samples were impacted and a performance issue related to vitros crea slide lot 7222-0021-3935 is not a likely contributor to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros crea slide lot 7219-0018-5809 or slide lot 7222-0021-3935.An instrument issue is an unlikely contributor to the event as diagnostic precision testing around the time the higher than expected results were obtained indicates acceptable performance of the vitros xt 3400 chemistry system.Pre-analytical sample processing is not a likely contributing factor as the higher than expected vitros crea results were isolated to only the affected patient samples and the results were reproducible.

• 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: 23383498
• Report Number: 1319809-2025-00086
• Device Sequence Number: 12934037
• Product Code: JFY
• UDI-Device Identifier: 10758750002849
• UDI-Public: (01)10758750002849(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): 10/23/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6802584
• 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: 09/29/2025
• Initial Report FDA Received Date: 10/24/2025
• 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