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	02/25/2026
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 samples from two different patients when processing vitros crea lot 1515-3583-9180 on a vitros xt 7600 integrated system.Additionally, a higher-than-expected result was obtained from one of the patient samples when processing vitros crea lot 1545-3582-6933 on a vitros xt 3400 chemistry system.The results were higher than expected when compared to the results obtained using an unknown method at an emergency room.Vitros xt 7600 integrated system, s/n (b)(6) (j1) vitros crea lot 1515-3583-9180: patient 1 vitros crea result of 2.33 mg/dl vs.The expected result of 0.86 mg/dl patient 2 vitros crea results of 3.14, 3.31, 3.07, 3.01, 2.99, 3.00, 2.86 mg/dl vs.The expected result of 1.23 mg/dl xt 3400 chemistry system, s/n (b)(6) (j2) using vitros crea lot 1545-3582-6933: patient 2 vitros crea results of 2.96 mg/dl vs.The expected result of 1.23 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 reported outside the laboratory and the patients were sent to the er for additional testing, where repeat testing produced results that were within expectation using an alternate, unknown method.It is unknown if a corrected report was issued.The customer did not administer treatment to either patient based on the higher-than-expected vitros crea results, and there was no allegation of patient harm as a result of the event.This report is number one of three mdrs for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment 613849.
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros creatinine (crea) results were obtained from samples from two different patients when processing vitros crea lot 1515-3583-9180 on a vitros xt 7600 integrated system.Additionally, a higher than expected result was obtained from one of the patient samples when processing vitros crea lot 1545-3582-6933 on a vitros xt 3400 chemistry system.The results were higher than expected when compared to the results obtained using an unknown method at an emergency room.The assignable cause of the event was unable to be determined.It is possible that an interferent was present in the affected patient samples, although this cannot be confirmed with the information provided.The vitros crea instructions for use (ifu), under limitation of the procedure, known interferences: serum and plasma -creatine: at a creatinine concentration of 1.5 mg/dl, creatine greater than 8 mg/dl will be flagged with a dp code (because highly elevated creatine concentrations may cause excessive background density).For unflagged samples, residual bias because of creatine will be less than 0.15 mg/dl.At a creatinine concentration of 14 mg/dl, creatine greater than 1 mg/dl will be flagged with a dp code.Residual bias for unflagged samples will be less than 2%.Refer to "sample dilution" for dilution instructions.-proline: patients receiving hyperalimentation fluids containing proline may show an increase of 0.2 mg/dl.Do not collect specimens from intravenous fluid lines contaminated with hyperalimentation fluid.-lidocaine: patients on long-term lidocaine therapy may show an increase of up to 1.0 mg/dl due to a metabolite of lidocaine, n-ethyl glycine (neg).The medication history of the patients was requested but not provided at the time of this report.A pre-analytical sample related issue cannot be completely ruled out as the customer was not following the sample collection device manufacturer's recommendations for sample centrifugation.It is likely that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Pre-analytical sample mix-up was not a likely cause of the event.The sample viscosity for the test events for both patients were similar, and sample height decreased as expected when the same tubes were tested.Historic vitros crea quality control results were acceptable within the timeframe of the event, indicating that vitros crea slide lot 1515-3583-9180 was performing as intended on the vitros xt7600 integrated system.Additionally, a vitros crea within run precision test confirmed that vitros crea lot 1515-3583-9180 was performing as expected in combination with the vitros xt7600 system.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros crea slide lot 1515-3583-9180 or 1545-3582-6933.A performance issue with the vitros xt7600 system did not likely contribute to the event, as a vitros alkp diagnostic within-run precision testing used to assess performance of the vitros xt7600 was within-in acceptance criteria.

• 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: 24706429
• Report Number: 1319809-2026-00028
• Device Sequence Number: 21471910
• Product Code: JFY
• UDI-Device Identifier: 10758750002849
• UDI-Public: (01)10758750002849(17)270401(11)251018(10)151535839180
• 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): 03/26/2026

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 Catalogue Number: 6802584
• Device Lot Number: 1515-3583-9180
• 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: 02/27/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2025
• 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