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	06/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher-than expected vitros intact pth (ipth) results were obtained from a single patient sample when tested on a vitros xt 7600 integrated system.The vitros ipth result was higher-than-expected when compared to an unknown non-vitros method for the same patient sample.A definitive assignable cause of the higher-than-expected vitros ipth result could not be determined.No issues were reported with the customers qc fluids, and no concerns were raised about the accuracy or precision of the vitros assay.The customer vitros ipth qc results were reviewed between the date of (b)(6) 2025 and were found to be within expected ranges.However, the qc level 1 and level 2 qc fluids were not processed on (b)(6) 2025 for lot 2120, preventing verification of assay performance on the day of the event.As no diagnostic precision testing was performed on the vitros xt 7600 system, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.Although, historical qc results were within expectation and there was no indication that the vitros xt 7600 integrated system malfunctioned.Pre-analytical sample processing could not be ruled out as a contributing factor, as it was unclear whether the customer followed the sample collection device manufacturer recommended centrifugation protocol.Improper handling during this phase may have contributed to the event.The presence of cellular debris due to inadequate sample preparation is a possibility, although this could not be confirmed.Additionally, the presence of an interferent affecting the vitros ipth method - but not the non-vitros ipth method may have contributed to the elevated patient sample results.However, no interference testing was performed to confirm this possibility.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth reagent lot 2120.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher-than expected vitros intact parathyroid hormone (ipth) results were obtained from a single patient sample when tested on a vitros xt 7600 integrated system.The vitros ipth result was higher-than-expected when compared to an unknown non-vitros method for the same patient sample.Patient 1 vitros ipth results of 10.40 and 10.25 pmol/l versus the expected result of 6.70 pmol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher-than-expected vitros ipth results were reported from the laboratory.The surgeon questioned the vitros results stating he did not think the ipth patient results should be high following a left inferior parathyroidectomy on 18-june-2025.It is not known if any corrected report was issued.Ortho has not been made aware of any allegation of patient harm as a result of this 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: 22540378
• Report Number: 3007111389-2025-00093
• Device Sequence Number: 18257429
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: (01)10758750006267(17)260112(11)250411(10)2120
• Combination Product (Y/N): N
• Initial Reporter Country: BA
• 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): 07/17/2025

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: 01/12/2026
• Device Catalogue Number: 6802892
• Device Lot Number: 2120
• 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: 07/02/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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