MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 350 CHEMISTRY SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6802153
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros ckmb results were obtained from vitros isoenzyme performance verifier (pv) quality control (qc) fluids processed on a vitros 350 chemistry system.The assignable cause of the event was an issue with the calibration parameters in use at the time of the event.The customer had periodic maintenance (pm) performed on 18 dec 2024.To enhance performance and maximize mean time between failures, it's recommended that the pm procedure be performed on all vitros 350 chemistry systems once a year.Pm for the vitros 350 chemistry system involves an extensive checklist of items that encompasses all analyzer subsystems.Per the "periodic maintenance procedure and checklist for the vitros 250, 250at, and 350 chemistry systems", system verification at the conclusion of pm includes processing qc fluids to confirm all tests are within their established limits, calibrate any tests that are not within the correct specification, and then repeat qc fluids to verify performance.The vitros ckmb qc results obtained by the customer were following the pm procedure using the same previously in-use calibration.Following a recalibration, the customers pv fluid qc results returned to expectation.Historical vitros ckmb lot 4917-0269-5318 quality control results were acceptable, indicating that a vitros ckmb reagent issue was not a likely contributor to the event.Within-run precision testing on the vitros 350 chemistry system was acceptable, indicating that and unexpected instrument performance was not a likely contributor to the event.Continual tracking and trending of complaints has not identified any signals that would point to a systemic issue with vitros ckmb lot 4917-0269-5318.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros ckmb results were obtained from vitros isoenzyme performance verifier (pv) quality control (qc) fluids processed on a vitros 350 chemistry system.Vitros isoenzyme pvi lot u1670 results of 12.0, 12.6, 14.4, 12.3 versus the expected result of 20.8 u/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 customer indicated that patient results were not affected because the qc results were unacceptable.There were no allegations 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 350 CHEMISTRY SYSTEM
• Common Device Name: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21196530
• Report Number: 1319681-2025-00002
• Device Sequence Number: 8292970
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: (01)10758750002054
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 01/17/2025

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 Catalogue Number: 6802153
• 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: 12/23/2024
• Initial Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2020
• 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