MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6802892
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros intact pth (ipth) results have occurred with multiple patient samples when comparing data from a method comparison study between the vitros ipth assay and the vitros ipth2 assay tested on a vitros xt 7600 integrated system.The vitros ipth reference interval: 7.5 - 53.5 pg/ml.The vitros ipth2 reference interval: 14.2 - 75.2 pg/ml.Correlation sample 5 vitros ipth result of 77.38 pg/ml (above the reference interval) vs.The vitros ipth2 result of 57.98 pg/ml (within the reference interval).Correlation sample 6 vitros ipth result of 121.08 pg/ml (above the reference interval) vs.The vitros ipth2 result of 67.43 pg/ml (within the reference interval).Correlation sample 21 vitros ipth result of 88.28 pg/ml (above the reference interval) vs.The vitros ipth2 result of 62.54 pg/ml (within the reference interval).Correlation sample 22 vitros ipth result of 78.44 pg/ml (above the reference interval) vs.The vitros ipth2 result of 59.59 pg/ml (within the reference interval).Correlation sample 23 vitros ipth result of 87.25 pg/ml (above the reference interval) vs.The vitros ipth2 result of 65.19 pg/ml (within the reference interval).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The customer performed the patient sample correlation in order to assess the bias between the vitros ipth and vitros ipth2 methods and no patient sample results were reported from the laboratory.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 607347.
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros intact pth (ipth) results have occurred with multiple patient samples when comparing data from a method comparison study between the vitros ipth assay and the vitros ipth2 assay tested on a vitros xt 7600 integrated system.The assignable cause could not be determined with the limited information provided.Vitros quality control fluids processed within the timeframe of the correlation testing were predicting as expected and no issues regarding accuracy or precision of the vitros assay were indicated by the customer.However, the customer was reporting higher than expected vitros ipth patient sample results, therefore, a reagent related performance issue cannot be completely ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth reagent lot 2010.No diagnostic within-run precision testing was performed on the vitros xt7600 integrated system, however, since the vitros ipth quality control results were acceptable, an instrument-related performance issue did not likely contribute to the event.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
• 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; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20179571
• Report Number: 3007111389-2024-00176
• Device Sequence Number: 8931244
• Product Code: CEW
• UDI-Device Identifier: 10758750031795
• UDI-Public: (01)10758750031795(17)250317(11)240611(10)2010
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/09/2024

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: 03/17/2025
• Device Catalogue Number: 6802892
• Device Lot Number: 2010
• 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: 08/13/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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