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

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	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros amon result was obtained from a vitros liquid performance verifier processed using vitros chemistry products ammonia (amon) slides lot 1020-0267-8941 on a vitros 350 chemistry system.The assignable cause of the lower than expected vitros amon result is an instrument issue related to ammonia contamination of the microslide incubator.The cause of the ammonia contamination was not determined.The results of a vitros amon within run precision test were not within expectations.An ortho field engineer (fe) traveled to the customer site to replace the incubator evaporation caps and springs, perform a periodic maintenance event and complete subsequent adjustments on the microslide incubator.Following service actions, the results of a vitros amon diagnostic precision test were within ortho acceptable guidelines, indicating that service actions performed by the ortho fe had resolved the issue.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected vitros amon result was obtained from a vitros liquid performance verifier (lpv) processed using vitros chemistry products ammonia (amon) slides lot 1020-0267-8941 on a vitros 350 chemistry system.Lpv ii lot k2576 vitros amon results of 128, 132, 137, 139, 142, 133.2, 132.5, and 119.6 umol/l versus the expected result of 182.0 umol/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 vitros amon results were obtained when processing a control fluid.No results were reported out of the laboratory.The customer claimed that patient results were not impacted by this issue, however, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.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 350 CHEMISTRY SYSTEM
• Common Device Name: CLINICAL CHEMISTRY
• 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: 22327386
• Report Number: 1319681-2025-00031
• Device Sequence Number: 9583070
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: (01)10758750002054(11)160721
• 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
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2016
• 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