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	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined the customer reported that higher than expected vitros crea results were obtained from a single patient sample tested on a vitros 5600 integrated system.The most likely assignable cause for the issue is an unknown sample interferent.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 5600 integrated system did not generate a vitros crea result when the patient sample was tested undiluted due to the occurrence of a dp sample code, which indicates substrate depletion.The most likely cause of the dp sample code 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.The historical quality control data review indicates the vitros crea slides did not likely contribute to the event, as the quality control results were acceptable during the timeframe of the event.In addition, continual tracking and trending did not indicate a performance issue with vitros crea slide lot 1515-3568-9586.The customer made no indication that there was a performance issue with the vitros 5600 integrated system.Historical quality control results indicated vitros crea slide lot 1515-3568- 9586 was performing as intended on the vitros 5600 integrated system.However, since no diagnostic within-run precision testing was performed to assess the performance of the vitros 5600 system, an instrument performance issue cannot be entirely ruled out as contributing to the event.Improper patient sample handling did not likely contribute to the event as the higher-than-expected vitros crea results were isolated to the affected sample, and the results were reproducible.
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 a single patient sample tested on a vitros 5600 integrated system.Patient sample vitros crea results of 180.9 and 188.8 umol/l vs.The expected roche creatinine result of 70.0 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 results of 180.9 and 188.8 umol/l were not reported outside of the laboratory and there was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number 32282912 and reportability assessment 611401.

• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 22521878
• Report Number: 1319809-2025-00059
• Device Sequence Number: 8560386
• Product Code: JFY
• UDI-Device Identifier: 10758750002849
• UDI-Public: (01)10758750002849(17)260701(11)2412226(10)151535689586
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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 Expiration Date: 06/01/2026
• Device Catalogue Number: 6802584
• Device Lot Number: 1515-3568-9586
• 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: 07/01/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2024
• 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