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	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros ipth results have occurred with multiple patient samples when comparing results between the vitros ipth assay and the vitros ipth2 assay tested on a vitros 5600 integrated system.The assignable cause could not be determined.Vitros quality control fluids processed within the timeframe of the comparison testing were performing as expected except for biorad control lot 65000 l3 controls.However, acceptable biorad l3 quality control performance was obtained using an alternate vitros ipth lot 2060.Therefore, a performance issue with vitros ipth reagent lot 2030 cannot be completely ruled out as a contributing factor 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 2030.No diagnostic within-run precision testing was performed to assess the performance of the vitros 5600 integrated system.However, acceptable vitros ipth performance was obtained using an alternate reagent lot with no actions taken to optimize the instrument performance.Therefore, an instrument related issue did not likely contribute to the event.
Event or Problem Description
The customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected vitros intact pth (ipth) results obtained on a vitros 5600 integrated system.The higher than expected vitros ipth results were obtained when performing a patient sample correlation with an alternate vitros site that was using the vitros intact pth ii (ipth2) assay.Sample 1 vitros ipth 139.3 pg/ml (above the reference interval) vs.Vitros ipth2 48.6 pg/ml (within the reference interval).Sample 2 vitros ipth 88.8 pg/ml (above the reference interval) vs.Vitros ipth2 49.1 pg/ml (within the reference interval).Sample 3 vitros ipth 114.7 pg/ml (above the reference interval) vs.Vitros ipth2 70.9 pg/ml (within the reference interval).Sample 4 vitros ipth 55.2 pg/ml (above the reference interval) vs.Vitros ipth2 28.0 pg/ml (within the reference interval).Biased results of the magnitude and direction observed may lead to inappropriate physician action if the results were to recur undetected.The higher than expected vitros ipth results were obtained as part of a comparison study and were not reported from the laboratory.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• 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: 21096700
• Report Number: 3007111389-2025-00004
• Device Sequence Number: 15687064
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: (01)10758750006267(17)250428(11)240725(10)2030
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2025

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: 04/28/2025
• Device Catalogue Number: 6802892
• Device Lot Number: 2030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown