MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS AMON SLIDES; IN-VITRO 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	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected ammonia (amon) result was obtained from a single patient sample and multiple higher than expected results were obtained from a standard source bio quality control processed using vitros chemistry products amon slides lot 1020-0267-1181 on a vitros 4600 chemistry system.Patient sample vitros amon result of 214.0 umol/l versus an expected result of 48.0 umol/l standard source bio control level 1 (lot unknown) vitros amon results of 207.0, 210.0, 207.0 and 203.0 umol/l vs an expected result of 167.667 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 patient sample result was not reported out of the laboratory.There have been no allegations of patient harm as a result of this event.This report is number four of five mdrs for this event.Five 3500a forms are being submitted for this event as five devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 614000.
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected ammonia (amon) result was obtained from a single patient sample and multiple higher than expected results were obtained from a standard source bio quality control processed using vitros chemistry products amon slides lot 1020-0267-1181 on a vitros 4600 chemistry system.A definitive assignable cause of the event could not be determined with the information provided.Based on historical quality control results, a vitros amon slides lot 1020-0267-1181 related issue cannot be entirely ruled out as a contributor of the events.Pre-analytical sample processing could not be ruled out as a contributing factor of the non-reproducible, higher than expected patient sample result as it is unknown if the customer was following the sample collection device manufacturers 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.A possible cause of the events is microslide incubator contamination.However, as no vitros amon within run precision testing was performed on the vitros 4600 system upon request, incubator contamination could not be entirely confirmed.An ortho field engineer has been scheduled to visit the customer site in order to perform the incubator decontamination procedure on the instrument which is expected to resolve the issue.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon lot 1020-0267-1181.

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24877940
• Report Number: 1319809-2026-00047
• Device Sequence Number: 15728351
• Product Code: JID
• UDI-Device Identifier: 10758750000012
• UDI-Public: (01)10758750000012(17)260801(11)250215(10)102002671181
• 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): 04/14/2026

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 Expiration Date: 08/01/2026
• Device Catalogue Number: 1726926
• Device Lot Number: 1020-0267-1181
• 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: 03/17/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2025
• 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