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

Catalog Number	6801709
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower-than-expected vitros vancomycin (vanc) result was obtained from a single patient sample using vitros vanc reagent lot 2514-57-3611 tested on a vitros xt 7600 integrated system.The patient sample result was lower than expected when compared to the result obtained from testing the same patient sample on an alternate non-vitros siemens methodology.Patient sample 18 vitros vanc results of 8.60 ug/ml vs.The expected result of 17.4 ug/ml 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 vanc result was obtained as part of patient correlation testing and was not reported from the laboratory.There has been no allegation 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).
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros vancomycin (vanc) result was obtained from a single patient sample using vitros vanc reagent lot 2514-57-3611 tested on a vitros xt 7600 integrated system.The patient sample result was lower than expected when compared to the result obtained from testing the same patient sample on an alternate non-vitros siemens methodology.The definitive assignable cause could not be determined with the information provided.Although vitros vanc lot 2514-57-3611 was a new lot at the time of the event and no historical results were available, individual results at the time of and after the event were accurate and precise, indicating a reagent performance issue is not a likely contributor to the event.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros vanc reagent lot 2514-57-3611.The patient 18 sample was collected on (b)(6) 2025 and initially processed on the siemans method.The patient sample was tested 16 days and 38 days later, on a vitros xt 7600 system on site and at an alternate site.The dates of testing of the patient 18 sample exceeded the vitros vanc instructions for use (ifu) for specimen stability, which states the sample is stable for maximum of 14 days if stored frozen.Ortho does not provide performance claims for samples processed outside of the stability guidelines; therefore, the age of the patient sample used for testing on the vitros cannot be ruled out as a contributor to the event.The vitros vanc patient result was reproducible across two vitros analyzers, demonstrating reproducibility across the vitros methodology.This finding would suggest that an unknown interferent that affected the vitros methodology but not the alternate siemens methodology could be a contributor to the event, although this could not be confirmed as the customer declined to provide any additional information related to the patient.No diagnostic within run precision testing was performed, however there was no indication of an instrument malfunction as evidenced by the acceptable quality control results observed at the time of the event.This demonstrates that a vitros xt 7600 integrated system issue is not a likely contributor to the event.No information was provided concerning the sample collection device(s), fluid handling protocol, or centrifugation protocol and manufacturer recommendations.Therefore, it was not possible to determine whether the customer was following the sample collection device manufactures recommendation for sample centrifugation.

• Brand Name: VITROS CHEMISTRY PRODUCTS VANC REAGENT
• 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.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24500144
• Report Number: 1319808-2026-00013
• Device Sequence Number: 9960707
• Product Code: LEH
• UDI-Device Identifier: 10758750006731
• UDI-Public: (01)10758750006731(17)260701(11)250801(10)573611
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: 07/01/2026
• Device Catalogue Number: 6801709
• Device Lot Number: 2514-57-3611
• 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: 02/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2025
• 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