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	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, lower than expected intact pth (ipth) results were obtained when samples from two different patients were tested using vitros ipth ii lot 0050 on a vitros xt 7600 integrated system.The results were discordant when compared to non-vitros diasorin ipth results for the same patient samples.Patient 8, vitros ipth ii result of 69.75 pg/ml (within the ri) versus a diasorin ipth result of 135 pg/ml (above the ri) patient 26, vitros ipth ii result of 6 pg/ml (below the ri) versus a diasorin ipth result of 14 pg/ml (within the ri) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, lower than expected vitros ipth2 results were obtained when vitros ipth2 validation testing was being performed as part of a menu expansion and the results were not 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 discordant, lower than expected intact pth (ipth) results were obtained when samples from two different patients were tested using vitros ipth ii lot 0050 on a vitros xt 7600 integrated system.The results were discordant when compared to non-vitros diasorin ipth results for the same patient samples.A definitive assignable cause could not be determined.The variability observed between the vitros ipth2 and diasorin ipth assays is not an unexpected 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.There was limited qc data to evaluate vitros ipth2 lot 0050 reagent performance, therefore a vitros ipth2 lot 0050 reagent issue cannot be ruled out as a contributor to the event.However, the limited qc results did demonstrate acceptable performance of vitros ipth2 lot 0050 and ongoing tracking and trending did not identify any signals to suggest there is a systemic quality issue with vitros ipth2 lot 0050.An instrument issue cannot be completely ruled out as contributing to the event as no precision testing was performed on the instrument.However, there is no evidence or any suggestion from the customer that the instrument was not performing as intended and vitros ipth2 results from qc testing for the short time period reviewed demonstrated acceptable instrument performance.The patient samples were tested at the customer site on the vitros xt 7600 integrated system, then sent frozen to an alternate site for diasorin ipth testing.It is possible a patient sample handling issue contributed to the event, however, this could not be confirmed.

• 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: 20577659
• Report Number: 3007111389-2024-00211
• Device Sequence Number: 8095401
• Product Code: CEW
• UDI-Device Identifier: 10758750032709
• UDI-Public: (01)10758750032709(17)251028(11)240123(10)0050
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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: 10/28/2025
• Device Catalogue Number: 6900052
• Device Lot Number: 0050
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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