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	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros ipth2 results have occurred with three different 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.Correlation sample 3 vitros ipth2 result of 34.6 pg/ml vs.The vitros ipth result of 70.8 pg/ml.Correlation sample 13 vitros ipth2 result of 140.2 pg/ml vs.The vitros ipth result of 253.2 pg/ml.Correlation sample 20 vitros ipth2 result of 34.6 pg/ml vs.The vitros ipth result of 70.5 pg/ml.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 in order to assess the bias between the vitros ipth2 and vitros ipth 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 is number two 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 number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros ipth2 results have occurred with three different 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 assignable cause could not be determined with the limited information provided.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 additionally, precision testing of the vitros xt 7600 integrated system 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 xt 7600 system malfunction.Therefore, an instrument issue is not a likely 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
This supplemental mdr files for additional samples that were deemed reportable after medical affairs consultation.The following results were initially reported based on a known 20% negative bias for the vitros ipth2 assay when compared to results obtained from the vitros ipth assay.Initially, the known 20% bias was removed from the vtros ipth results when assessing the vitros ipth2 results for potential reporting.The following vitros ipth2 results were initially reported: correlation sample 3 vitros ipth2 result of 34.6 pg/ml vs.The vitros ipth result of 70.8 pg/ml.Correlation sample 13 vitros ipth2 result of 140.2 pg/ml vs.The vitros ipth result of 253.2 pg/ml.Correlation sample 20 vitros ipth2 result of 34.6 pg/ml vs.The vitros ipth result of 70.5 pg/ml.On 17 october 2024, a medical consultation was performed with ortho medical scientific & clinical affairs and it was determined the 20% bias should not have been removed when assessing for potential health and safety criteria, with the following rationale: the ipth is not standardized, so it is expected to see some variability in the results.Though there is a known average bias of approximately 20% between the two tests, the range of observed bias might be a better estimate of determining if one test is erroneous compared to the other.Because both tests might be correct and what is observed might just be normal variation between the assays.For this comparison, assess the test results in relation to the reference range, i.E., is one test normal and the other abnormal.After comparing vitros ipth2 results to vitros ipth results in relation to the reference interval, the vitros ipth2 result obtained from correlation sample 13 no longer meets the criteria for a reportable result.In addition, additional vitros ipth2 results obtained from six different correlation patient samples meet the criteria for a reporting based on result discordance when compared to the reference intervals.Correlation sample 1 vitros ipth2 result of 36.3 pg/ml (within the reference interval) vs.The vitros ipth result of 54.5 pg/ml (above the reference interval).Correlation sample 2 vitros ipth2 result of 65.9 pg/ml (within the reference interval) vs.The vitros ipth result of 114.2 pg/ml (above the reference interval).Correlation sample 3 vitros ipth2 result of 34.6 pg/ml (within the reference interval) vs.The vitros ipth result of 70.8 pg/ml (above the reference interval).**initially reported.Correlation sample 4 vitros ipth2 result of 62.7 pg/ml (within the reference interval) vs.The vitros ipth result of 101.3 pg/ml (above the reference interval).Correlation sample 14 vitros ipth2 result of 52.4 pg/ml (within the reference interval) vs.The vitros ipth result of 86.1 pg/ml (above the reference interval).Correlation sample 18 vitros ipth2 result of 35.5 pg/ml (within the reference interval) vs.The vitros ipth result of 62.5 pg/ml (above the reference interval).Correlation sample 19 vitros ipth2 result of 62.3 pg/ml (within the reference interval) vs.The vitros ipth result of 103.3 pg/ml (above the reference interval).Correlation sample 20 vitros ipth2 result of 34.6 pg/ml (within the reference interval) vs.The vitros ipth result of 70.5 pg/ml (above the reference interval).Initially reported.This report is number two 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 number (b)(4) and reportability assessment 607735.
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros ipth2 results have occurred with three different 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 assignable cause could not be determined with the limited information provided.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 additionally, precision testing of the vitros xt 7600 integrated system 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 xt 7600 system malfunction.Therefore, an instrument issue is not a likely 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.

• 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: 20469768
• Report Number: 3007111389-2024-00205
• Device Sequence Number: 7519248
• 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: IN
• 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,Followup
• Report Date (Section B): 10/15/2024

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: 09/16/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/14/2024
• 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