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

Catalog Number	6801709
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower and higher than expected vitros vanc results were obtained from a two different levels of vitros therapeutic drug monitoring performance verifier (tdm pv) fluids tested on a vitros xt 7600 integrated system.Vitros tdm pv i lot c2150 results of 15.55, 15.42, 19.99 and 20.49 ug/ml vs.The baseline mean of 7.73 ug/ml vitros tdm pv iii lot e2152 results of <5.0, <5.0, <5.0, <5.0 ug/ml and 7.44 ug/ml vs.The baseline mean of 32.0 ug/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower and higher than expected results were obtained from non-patient quality control fluids.The customer made no allegation that erroneous patient results had been reported from the laboratory.There was no allegation of patient harm as a result of this event.This report is number two of three mdrs for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation has determined that lower and higher than expected vitros vancomycin (vanc) results were obtained from a two different levels of vitros therapeutic drug monitoring performance verifier (tdm pv) fluids tested on a vitros xt 7600 integrated system.The assignable cause of the vitros vanc results of 15.55, 15.42, 19.99 and 20.49 ug/ml was a suboptimal calibration.The issue occurred following calibration of vitros vanc reagent lot 2514-56-2676.The calibration responses and parameters obtained from the affected calibration appeared atypical to expected responses and parameters.Acceptable performance was obtained after performing an additional calibration event where the calibration responses and parameters appeared atypical to expected responses and parameters.The cause of the suboptimal calibration is unknown.The assignable cause of the vitros vanc results of <5.0, <5.0, <5.0, <5.0 ug/ml and 7.44 ug/ml could not be determined.Based on historical quality control results, a vitros vanc reagent lot 2514-56-2676 was performing as intended prior to the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros vanc reagent lot 2514-56-2676.The vitros vanc results shifted low on both vitros tdm pv levels using pack id (b)(4) and calibration curve (b)(4).It is noted that acceptable vitros vanc results were obtained from both tdm pv levels prior to the event using pack id (b)(4).In addition, calibration curve (b)(4) was in use since vitros vanc reagent lot 2514-56-2676 was initially put into use on 30 january 2025.This indicates the event was not reagent pack or calibration driven.Diagnostic within-run precision testing to assess the performance of the vitros xt 7600 integrated system was not performed, therefore, an instrument related performance issue cannot be ruled out as contributing to the event.However, acceptable vitros vanc lot 2514-56-2676 performance was obtained after calibrating with an alternate reagent pack without taking any action to optimize the vitros xt 7600 integrated system.Therefore, an instrument related performance issue did not likely contribute to the event.

• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21761193
• Report Number: 1319808-2025-00014
• Device Sequence Number: 12884394
• Product Code: LEH
• UDI-Device Identifier: 10758750006731
• UDI-Public: (01)10758750006731(17)250609(11)240709(10)562676
• 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): 04/02/2025

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: 06/09/2025
• Device Catalogue Number: 6801709
• Device Lot Number: 2514-56-2676
• 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: 03/13/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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