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

Catalog Number	1037274
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected vitros acetaminophen (acet) result was obtained from a single patient sample tested on a vitros 5600 integrated system.The result was lower than expected when compared to the initial result from the same patient sample.Patient sample 1 vitros acet repeat result of < 2.0 mg/dl vs.The initial result of > 20.0 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros acet result was not reported from the laboratory and there has been no allegation of harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment 612879.
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros acetaminophen (acet) result was obtained from a single patient sample tested on a vitros 5600 integrated system.The result was lower than expected when compared to the initial result from the same patient sample.A definitive cause of the event could not be determined given the limited information provided.The customer did not provide baseline mean/sd values, package insert (pi) values, and/or randox peer values to the ortho tsc when requested.This information would be used to evaluate the customers historic vitros acet quality control (qc) results leading up to the day of the event.As this information was not provided, historic qc results were unable to be evaluated.Therefore, a vitros acet slide lot 2918-0077-1305 performance issue cannot be completely ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros acet slide lot 2918-0077-1305.As of the date of writing this report, no vitros alkp diagnostic precision testing has been performed; therefore, an instrument related issue cannot be ruled out as contributing to the event.Pre-analytical sample mix-up was not a likely contributor to the event, as a review of the sample viscosities and zee-height measurements showed consistent results between the initial and repeat of sample 1, indicating that the same sample was processed.It is unknown if the customer was following the collection device manufacturers specifications for centrifugation, therefore, improper pre-analytical sample processing could not be ruled out as contributing 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.

• Brand Name: VITROS CHEMISTRY PRODUCTS ACET 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: 23821474
• Report Number: 1319809-2025-00101
• Device Sequence Number: 15978706
• Product Code: LDP
• UDI-Device Identifier: 10758750008339
• UDI-Public: (01)10758750008339(17)260801(11)250219(10)291800771305
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/16/2025

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 Expiration Date: 08/01/2026
• Device Catalogue Number: 1037274
• Device Lot Number: 2918-0077-1305
• 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: 11/21/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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