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

Catalog Number	6900052
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the (b)(6) to report lower than expected vitros ipth2 results have occurred with multiple patient samples when comparing data from a method comparison study between the vitros ipth2 assay and the vitros ipth assay on a vitros 3600 immunodiagnostic system.Correlation sample 2 vitros ipth2 result of 44.4 pg/ml (within the reference interval) vs.The vitros ipth result of 64.1 pg/ml (above the reference interval).Correlation sample 3 vitros ipth2 result of 58.0 pg/ml (within the reference interval) vs.The vitros ipth result of 86.5 pg/ml (above the reference interval).Correlation sample 8 vitros ipth2 result of 41.0 pg/ml (within the reference interval) vs.The vitros ipth result of 61.8 pg/ml (above the reference interval).Correlation sample 17 vitros ipth2 result of 51.0 pg/ml (within the reference interval) vs.The vitros ipth result of 74.9 pg/ml (above the reference interval).Correlation sample 18 vitros ipth2 result of 38.0 pg/ml (within the reference interval) vs.The vitros ipth result of 54.4 pg/ml (above the reference interval).Correlation sample 19 vitros ipth2 result of 42.4 pg/ml (within the reference interval) vs.The vitros ipth result of 60.9 pg/ml (above the reference interval).Correlation sample 20 vitros ipth2 result of 58.8 pg/ml (within the reference interval) vs.The vitros ipth result of 86.9 pg/ml (above the reference interval).Correlation sample 24 vitros ipth2 result of 42.7 pg/ml (within the reference interval) vs.The vitros ipth result of 61.1 pg/ml (above the reference interval).Correlation sample 25 vitros ipth2 result of 53.2 pg/ml (within the reference interval) vs.The vitros ipth result of 77.9 pg/ml (above 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 as part of a system correlation testing for menu expansion 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 (b)(4).
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros ipth2 results have occurred with multiple patient samples when comparing data from a method comparison study between the vitros ipth2 assay and the vitros ipth assay on a vitros 3600 immunodiagnostic system.The variability observed between the vitros ipth2 and ipth assays is an expected outcome, given the lack of standardization across ipth measurement methods.Differences in assay design, antibody selection, and various circulating fragments contribute to the well-documented inter-method discrepancies in pth measurement.Ortho had previously communicated that the vitros ipth assay was approximately 20% higher than a non-vitros roche method.The vitros ipth2 assay has eliminated that 20% high bias.Therefore, there is an expected 20% bias between ipth and ipth2 which is the most likely cause of the numerical discordance.There is no indication the vitros ipth2 reagent in use at the time of the event was not performing as intended as vitros quality control fluids processed within the timeframe of the correlation testing were predicting as expected and no issues regarding accuracy of the vitros assay were indicated by the customer.No diagnostic within-run precision testing was performed on the vitros 3600 immunodiagnostic system, however, both vitros ipth reagent lot 2070 and vitros ipth2 reagent lot 0145 were performing as intended prior to, and on the day of the event, an instrument-related performance issue did not likely contribute to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth2 reagent lot 0145.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH II 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: 21654901
• Report Number: 3007111389-2025-00023
• Device Sequence Number: 12646282
• Product Code: CEW
• UDI-Device Identifier: 10758750032709
• UDI-Public: (01)10758750032709(17)250811(11)241104(10)0145
• Combination Product (Y/N): N
• 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): 03/20/2025

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: 08/11/2025
• Device Catalogue Number: 6900052
• Device Lot Number: 0145
• 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: 02/21/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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