MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS

Catalog Number	1882208
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher-than-expected lactate result was obtained from a patient sample processed during a reagent lot to lot correlation using vitros chemistry products lactate (lac) slides lot 3533-0130-3002 on a vitros xt 7600 integrated system.Patient sample result of 11.5 mmol/l vs an expected result of 9.9 mmol/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 lac result was obtained during a reagent lot to lot correlation and was not reported from the laboratory.There has been no reported 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 has determined that a higher-than-expected lactate result was obtained from a patient sample processed during a reagent lot to lot correlation using vitros chemistry products lac slides lot 3533-0130-3002 on a vitros xt 7600 integrated system.The assignable cause of the higher-than-expected vitros lac result is related to the calibration in use at the time of the initial patient correlation.The issue with the initial calibration could not be confirmed.Although the calibration parameters for the initial and repeat calibrations were both typical, the patient correlation results were higher than expected when run using the initial calibration.Following a recalibration event using an alternate lot of vitros calibrator kit 1, an acceptable result for the same patient sample was obtained with no other actions performed on the vitros xt7600 system.The customer stated that they follow the protocol in the vitros calibrator kit 1 instructions for use when preparing the calibrator kit vials.However, no further specific information was provided and an issue related to improper protocol cannot be entirely ruled out as a contributing factor of the suboptimal calibration.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros lac reagent lot 3533-0130-3002.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
• 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: 22282912
• Report Number: 1319808-2025-00024
• Device Sequence Number: 15672454
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: (01)10758750000166(17)261007(11)241007(10)0114
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/16/2025

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 Catalogue Number: 1882208
• Device Lot Number: 0114
• 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: 05/29/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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