MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9; IN-VITRO DIAGNOSTICS

Catalog Number	8568040
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	08/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that both lower and higher than expected vitros therapeutic drug monitoring (tdm) performance verifier (pv) quality control results were obtained when processing two different vitros carbamazepine (crbm) slide lots using a vitros xt 7600 integrated system.The investigation concludes that the likely cause of this event was suboptimal calibrations.The issue occurred following calibration of new vitros crbm slide lots.The calibration responses and parameters obtained from all the affected calibrations appeared atypical to expected responses and parameters.No information was provided concerning the handling of the calibrator fluids prior to calibrating.Therefore, improper calibrator handling protocol cannot be ruled out as contributing to the event.A successful within run diagnostic precision test concludes the vitros xt 7600 system was performing as expected and an instrument issue has been ruled out as a contributor to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential issue with vitros crbm lots 3916-0125-1727 or 3916-0125-1782.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower and higher than expected vitros therapeutic drug monitoring (tdm) performance verifier (pv) quality control results were obtained when processing two different vitros carbamazepine (crbm) slide lots using a vitros xt 7600 integrated system.Vitros crbm slide lot 3916-0125-1727: vitros tdm pv i y1734 results of 7.95 and 7.84 ug/ml versus the baseline mean value of 4.82 ug/ml vitros tdm pv iii b1736 results of 8.88, >20, >20, >20 and >20 ug/ml versus the baseline mean value of 13.32 ug/ml vitros crbm slide lot 3916-0125-1782: vitros tdm pv iii b1736 results of 9.31, 18.31, 17.92, 17.63, 18.52, 18.87, 17.4, 18.1, 17.8, 17.9, 18.4 and 17.6 ug/ml versus the baseline mean value of 13.32 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 higher and lower than expected results were obtained from non-patient quality control fluids.The customer made no allegation that patient results were affected or reported from the laboratory.There was no allegation of patient harm as a result of this event.This report is number six of six mdrs for this event.Six 3500a forms are being submitted for this event as six devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment 607359.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9
• 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: 20193724
• Report Number: 1319808-2024-00034
• Device Sequence Number: 12643832
• Product Code: JIT
• UDI-Device Identifier: 10758750005031
• UDI-Public: (01)10758750005031(17)250814(11)230814(10)0963
• 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): 09/11/2024

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: 08/14/2025
• Device Catalogue Number: 8568040
• Device Lot Number: 0963
• 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: 08/16/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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