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

Catalog Number	8343386
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros digoxin (dgxn) results were obtained from a non-vitros biorad quality control processed using vitros chemistry products dgxn slides lot 1935-0272-7462 on a vitros 5600 integrated system.The investigation could not determine an assignable cause of the lower than expected qc results.An issue related to the biorad level 3 control fluid could not be confirmed or ruled out as a contributor of the lower than expected results as no information was provided about the customer's protocol regarding the biorad control fluids or how many vials were used during the timeframe of the event.Based on historical quality control results using all three levels of the biorad controls, an issue related to vitros dgxn slides lot 1935-0272-7462 could not be ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros dgxn lot 1935-0272-7462.Vitros crbm diagnostic precision testing as well as vitros dgxn within run precision testing results processed on the vitros 5600 integrated system were within ortho acceptable guidelines.However, as no known precision testing was performed around the initial timeframe of the event, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros digoxin (dgxn) results were obtained from a non-vitros biorad quality control processed using vitros chemistry products dgxn slides lot 1935-0272-7462 on a vitros 5600 integrated system.Biorad lot 85350 level 3 results of 1.97, 1.42, 1.41, 1.91, 1.92, 1.95, 2.01, 1.98, 1.86, 2.01, 1.64, 2.01, 1.92, 2.00, 1.52, 1.58 and 1.80 nmol/l vs.The expected result of 2.688 nmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower-than-expected results were from a non-patient quality control fluid and were not reported outside of the laboratory.There have been no reported allegations of patient harm as a result of this event.This report is number thirteen of seventeen mdrs for this event.Seventeen 3500a forms are being submitted for this event as seventeen devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS DGXN 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: 21630757
• Report Number: 1319809-2025-00043
• Device Sequence Number: 8330926
• Product Code: LFM
• UDI-Device Identifier: 10758750004782
• UDI-Public: (01)10758750004782(17)250315(11)241023(10)193502727462
• 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): 03/17/2025

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: 03/15/2025
• Device Catalogue Number: 8343386
• Device Lot Number: 1935-0272-7462
• 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: 02/18/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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