MAUDE Adverse Event Report: Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products AMON Slides; In-Vitros Diagnostics

Catalog Number	1726926
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An ortho field application specialist (fas) on behalf of a customer, contacted the ortho clinical diagnostics (ortho) global technical solutions center (tsc) to report a non-reproducible, higher than expected vitros amon result was obtained from a single patient sample processed using vitros chemistry products amon slides lot 1022-0269-7519 on a vitros xt 3400 chemistry system.Patient sample vitros amon result of 261.1 umol/l versus an expected result of 114.7 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, higher than expected vitros amon result was not reported out of the laboratory.There have been 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 615879.
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected vitros amon result was obtained from a single patient sample processed using vitros chemistry products amon slides lot 1022-0269-7519 on a vitros xt 3400 chemistry system.A definitive assignable cause of the event could not be determined with the information provided.Based on historical quality control results for vitros amon lot 1022-0269-7519, a reagent related issue is not a likely contributing factor of the event.The ortho fas reported that the non-reproducible, higher than expected vitros amon result was obtained using the first microslide from a fresh reagent cartridge.Additionally, the ortho fas confirmed that results from the remainder of the affected reagent cartridge have been within expectations.An individual slide related issue cannot be ruled out as a contributing factor of the event.A within run precision test processed on the vitros xt 3400 system yielded results that were within ortho acceptable guidelines.An instrument related issue is not a likely contributing factor of the event.Pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturer recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon lot 1022-0269-7519.

• Brand Name: VITROS Chemistry Products AMON Slides
• Common Device Name: In-Vitros 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; +1(585)453-4165
• MDR Report Key: 50899006
• Report Number: 1319809-2026-00140
• Device Sequence Number: 17605568
• Product Code: JID
• UDI-Device Identifier: 10758750000012
• UDI-Public: (01)10758750000012(17)270201(11)250830(10)102202697519
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/24/2026

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: 1726926
• Device Lot Number: 1022-0269-7519
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2025
• 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