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	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected vitros ammonia (amon) result was obtained from a single patient sample processed using vitros chemistry products amon slides lot 1020-0267-3614 on a vitros 5600 integrated system.The result was higher than expected when compared to a repeat result from the same sample obtained on the sites vitros 4600 chemistry system.A definitive assignable cause of the event could not be determined with the information provided.A possible cause of the event is microslide incubator contamination as the results of a pre-maintenance precision test were close to the limits of the ortho acceptable guidelines.However, as the results were within the guidelines and the initial patient sample was not repeated on the vitros 5600 system, an instrument related issue could not confirmed or ruled out as the cause of the event.The ortho field application specialist (fas) performed the ammonia decontamination procedure on the vitros 5600 system and a post maintenance precision test confirmed that the performance of the instrument was optimized.No quality control results to verify the performance of vitros amon lot 1020-0267-3614 were provided and a reagent related issue could not be ruled out as a contributing factor of the event.However, the ortho fas stated that quality control results for vitros amon were within expectations.Pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not 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.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon lot 1020-0267-3614.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected vitros ammonia (amon) result was obtained from a single patient sample processed using vitros chemistry products amon slides lot 1020-0267-3614 on a vitros 5600 integrated system.The result was higher than expected when compared to a repeat result from the same sample obtained on the sites vitros 4600 chemistry system.Patient sample vitros amon result of 153.0 umol/l versus an expected result of 8.1 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 reported 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 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: 23865072
• Report Number: 1319809-2025-00103
• Device Sequence Number: 14562351
• Product Code: JID
• UDI-Device Identifier: 10758750000012
• UDI-Public: (01)10758750000012(17)261101(11)250503(10)102002673614
• 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): 12/19/2025

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: 1726926
• Device Lot Number: 1020-0267-3614
• 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: 12/03/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2025
• 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