MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS AMON SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number	1721869
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concludes that a higher-than-expected result was obtained from a single patient sample using vitros ammonia (amon) slide lot: 1020-0268-5934 on a vitros 4600 chemistry system.The assignable cause of the event could not be determined with the information provided.The customer did not provide enough quality control data generated for vitros amon slide lot: 1020-0268-5934 to assess the performance of the slide lot, therefore, a performance issue with vitros amon slide lot: 1020-0268-5934 cannot be ruled out as contributing to the event.An instrument related performance issue did not likely contribute to the event as a vitros amon within-run precision test was within the acceptance criteria.No information was provided concerning the affected sample or how the sample was collected, processed and stored prior to testing.Therefore, it was not possible to establish if the customer is following the sample collection device manufacturer recommendation for sample centrifugation therefore improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher-than-expected result was obtained from a single patient sample using vitros ammonia (amon) slide lot: 1020-0268-5934 on a vitros 4600 chemistry system.Patient sample vitros amon result of 182.7 umol/l vs.The expected result of 28.2 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher-than-expected vitros amon result was not reported outside the laboratory and there was no allegation of patient harm.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (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: 24482889
• Report Number: 1319809-2026-00014
• Device Sequence Number: 21501881
• Product Code: JID
• UDI-Device Identifier: 10758750009602
• UDI-Public: (01)10758750009602(17)270101(11)250713(10)102002685934
• 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): 02/27/2026

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: 1721869
• Device Lot Number: 1020-0268-5934
• 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: 02/02/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2025
• 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