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	01/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher-than-expected vitros intact pth (ipth) quality control (qc) result was obtained when using non-vitros biorad quality control (qc) fluid lot 64990 on a vitros xt 7600 integrated system.A definitive cause for the higher-than-expected qc fluid result is unknown.An instrument issue cannot be completely ruled out as a contributing factor.No precision testing was performed on the vitros xt 7600 integrated system at the time of the event.Additionally, some accuracy and precision issues were identified during a review of the customer's historical vitros qc fluid results and therefore, a reagent related issue cannot be ruled out as a contributor of the event.The customer obtained condition codes specific to the microwell incubator, prompting an ortho field engineer (fe) to visit the site for microwell incubator optimization.Following the ortho fe's actions, additional qc fluid testing was conducted, which identified further accuracy issues.The ortho tsc continues to work with the customer on monitoring the qc results.Additionally, a vitros tsh diagnostic precision test was performed following the ortho fe's actions.The results were within ortho's acceptable guidelines, indicating that the vitros xt 7600 integrated system was performing as intended following the service actions.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth reagent lot 2070.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher-than-expected vitros intact pth (ipth) quality control (qc) result was obtained when using non-vitros biorad quality control (qc) fluid lot 64990 on a vitros xt 7600 integrated system.Vitros ipth lot 2070 biorad level 1 qc result of 31.15 pg/ml vs the expected result of 23.79 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher-than-expected vitros ipth result was obtained when the customer was processing non-patient fluids.The customer made no indication that any patient sample results had been affected, however, the investigation cannot conclude that patient samples would not be affected if the event were to reoccur undetected.There has been no allegation of harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers 400247330, 400250793 and reportability assessment 609306.

• 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: 21707022
• Report Number: 3007111389-2025-00027
• Device Sequence Number: 4656234
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: (01)10758750006267(17)250721(11)241014(10)2070
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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: Other
• Device Expiration Date: 07/21/2025
• Device Catalogue Number: 6802892
• Device Lot Number: 2070
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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