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	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that lower than expected results were obtained from a single level of non-vitros biorad liquichek tdm controls, lot 1002900 and from two different patient samples using vitros vancomycin (vanc) lot 2514-57-3072 tested on a vitros 5600 integrated system.The assignable cause of the lower than expected results was a reagent pack related issue.The affected vitros vanc results were isolated to a single reagent pack, pack id 6187.The assignable cause of the issue with the affected reagent pack was a high ambient temperature inside the laboratory that caused analyzer cooler errors that led to increased temperature in the reagent supply.It is likely the increased temperature in the reagent supply affected pack id 6187.Acceptable performance was obtained using an alternate reagent pack of vitros vanc reagent lot 2514-57-3072.A review of historic vitros vanc quality control results using reagent lot 2514-57-3072 prior to the event were reviewed and the customer did experience unacceptable within-lab precision prior to the event.The customer did not provide a timeframe for when the ambient temperature in the laboratory was high, therefore, it is possible the within-lab imprecision was caused by the same high temperature issue, however, this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros vanc reagent lot 2514-57-3072.There is no indication the vitros 5600 integrated system malfunctioned as acceptable vitros vanc performance was obtained using alternate reagent packs of the same lot numbers without performing any actions to optimize instrument performance.This indicates the vitros 5600 integrated system did not likely contribute to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected results were obtained from a single level of non-vitros biorad liquichek tdm controls, lot 1002900 and from two different patient samples using vitros vanc lot 2514-57-3072 tested on a vitros 5600 integrated system.Non-vitros biorad level 3 control result of <5 ug/ml vs.The expected result of 30.30 ug/ml patient 1 sample vitros vanc results of <5 and <5 ug/ml vs.The expected result of 16.87 ug/ml patient 2 sample vitros vanc results of <5 and <5 ug/ml vs.The expected result of 21.84 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 results obtained from the patient 1 and patient 2 samples were not reported outside of the laboratory and there was 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).

• 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: 23801886
• Report Number: 1319808-2025-00034
• Device Sequence Number: 7622217
• Product Code: LEH
• UDI-Device Identifier: 10758750006731
• UDI-Public: (01)10758750006731(17)251217(11)250117(10)573072
• 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): 12/15/2025

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: 12/17/2025
• Device Catalogue Number: 6801709
• Device Lot Number: 2514-57-3072
• 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: 11/18/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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