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	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower and higher 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 xt 7600 integrated system.A definitive assignable cause could not be determined.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 or precision of the vitros assay were indicated by the customer.Additionally, precision testing of the vitros xt7600 integrated systems was not performed, therefore, no assessment of the instrument's performance at the time of the event was made.However, the customer gave no indication of any vitros xt7600 system malfunction and since two different vitros instruments were affected, it is unlikely an instrument performance issue is a contributor 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: 0100.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower and higher 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 xt 7600 integrated system.The vitros ipth2 reference interval: 1.5 - 8.0 pmol/l the vitros ipth reference interval: 1.4 - 9.1 pmol/l j76001152 correlation sample 2 vitros ipth2 result of 7.70 pmol/l (within the reference interval) vs.The vitros ipth result of 11.52 pmol/l (above the reference interval).Correlation sample 7 vitros ipth2 result of 7.30 pmol/l (within the reference interval) vs.The vitros ipth result of 10.88 pmol/l (above the reference interval).Correlation sample 21 vitros ipth2 result of 6.11 pmol/l (within the reference interval) vs.The vitros ipth result of 9.96 pmol/l (above the reference interval).Correlation sample 27 vitros ipth2 result of 7.08 pmol/l (within the reference interval) vs.The vitros ipth result of 10.66 pmol/l (above the reference interval).J76001174 correlation sample 21 vitros ipth2 result of 6.67 pmol/l (within the reference interval) vs.The vitros ipth result of 10.48 pmol/l (above the reference interval).Correlation sample 22 vitros ipth2 result of 1.50 pmol/l (within the reference interval) vs.The vitros ipth result of 0.77 pmol/l (below the reference interval).Correlation sample 27 vitros ipth2 result of 7.61 pmol/l (within the reference interval) vs.The vitros ipth result of 11.08 pmol/l (above the reference interval).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 (cl2016-196) 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.The ipth2 results obtained in the correlation study are >20% biased to the ipth results and therefore are reportable.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 one of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers: (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: 20492528
• Report Number: 3007111389-2024-00204
• Device Sequence Number: 4106267
• Product Code: CEW
• UDI-Device Identifier: 10758750032709
• UDI-Public: (01)10758750032709(17)250204(11)240503(10)0100
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/18/2024

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: 02/04/2025
• Device Catalogue Number: 6900052
• Device Lot Number: 0100
• 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: 09/19/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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