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	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concludes that higher than expected vitros creatinine (crea) results were obtained from a patient sample pool tested on a vitros xt 7600 integrated system after storage at -20c for 15 days, 1 month, 2 months and 3 months.The most likely assignable cause of the event is likely changes from long term storage of the samples.Per the vitros crea instructions for use (ifu), samples can be stored frozen at
Event or Problem Description
An ortho clinical diagnostics (ortho) employee became aware of an article published in gaims journal of medical sciences that documented how prolonged storage of samples can result in changes to routine biochemical parameters.Higher than expected vitros creatinine (crea) results were obtained from a patient sample pool tested on a vitros xt 7600 integrated system after storage at -20c for 15 days, 1 month, 2 months and 3 months.Patient pool vitros crea results of 1.51 (15 days), 1.80 (1 month), 1.80 (2 months) and 2.0 (3 months) mg/dl vs.The expected time 0 vitros crea result of 0.70 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 patient sample results were not reported outside of the laboratory.There has been no reported 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21583655
• Report Number: 1319809-2025-00027
• Device Sequence Number: 15642808
• Product Code: JFY
• UDI-Device Identifier: 10758750002849
• UDI-Public: (01)10758750002849
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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: 6802584
• Device Lot Number: NOT PROVIDED
• 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: 02/14/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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