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 Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher and lower than expected vitros ipth2 results have occurred while processing patient correlation samples when comparing data from a method comparison study between two reagent lots of the vitros ipth2 assay and two reagent lots the vitros ipth assay on a vitros xt7600 integrated system.A definitive assignable cause could not be determined.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 intermethod 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 reagents in use at the time of the event was not performing as intended, however as no vitros quality control fluids were processed within the timeframe of the correlation testing this could not be definitively confirmed.No diagnostic within-run precision testing was performed on the vitros xt7600 integrated system, however, there was no indication that the instrument was not performing as expected based on the acceptable vitros ipth reagent lot 2090 qc results.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth2 reagent lots 0180 and 0080.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report that higher and lower than expected vitros ipth2 results occurred while processing patient correlation samples when comparing data from a method comparison study between two reagent lots of the vitros intact pth ii (ipth2) assay and two reagent lots the vitros intact parathyroid hormone (ipth) assay on a vitros xt7600 integrated system.Ipth2 lot 0080 versus ipth lot 2010 correlation sample 3 vitros ipth2 result of 100.9 pg/ml (above the reference interval) vs.The vitros ipth result of 51.7 pg/ml (within the reference interval).Correlation sample 5 vitros ipth2 result of 12.6 pg/ml (below the reference interval) vs.The vitros ipth result of 16.9 pg/ml (within the reference interval).Correlation sample 7 vitros ipth2 result of 41.5 pg/ml (within the reference interval) vs.The vitros ipth result of 58.4 pg/ml (above the reference interval).Correlation sample 8 vitros ipth2 result of 11.8 pg/ml (below the reference interval) vs.The vitros ipth result of 16.5 pg/ml (within the reference interval).Correlation sample 12 vitros ipth2 result of 12.5 pg/ml (below the reference interval) vs.The vitros ipth result of 25.4 pg/ml (within the reference interval).Ipth2 lot 0180 versus ipth lot 2090 correlation sample 16 vitros ipth2 result of 23.9 pg/ml (within the reference interval) vs.The vitros ipth result of 70.3 pg/ml (above the reference interval).Correlation sample 18 vitros ipth2 result of 24.4 pg/ml (within the reference interval) vs.The vitros ipth result of 73.4 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 is number two of two 3500a forms being submitted for this event as two devices were involved.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 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: 22481730
• Report Number: 3007111389-2025-00082
• Device Sequence Number: 8040965
• Product Code: CEW
• UDI-Device Identifier: 10758750032709
• UDI-Public: (01)10758750032709(17)241202(11)240226(10)0080
• 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): 07/09/2025

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: 12/02/2024
• Device Catalogue Number: 6900052
• Device Lot Number: 0080
• 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: 06/17/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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