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	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected intact pth (ipth) results were obtained when a non-vitros, biorad, qc fluid was tested using vitros ipth lot 2030 on a vitros xt 7600 integrated system.A definitive cause of the event was not established.Historical qc results indicate acceptable vitros ipth lot 2030 performance and ongoing tracking and trending did not identify any signals to suggest there is a systemic quality issue with vitros ipth lot 2030.However, the higher than expected results were isolated to vitros ipth lot 2030 testing of the biorad level 1 qc and the biorad qc results have been acceptable since vitros ipth lot 2070 was in use.Therefore, a vitros ipth lot 2030 performance issue cannot be completely ruled out as a contributor to the event.An instrument related issue is an unlikely contributor to the event, however, as there was no diagnostic precision testing conducted to verify the performance of the vitros xt 7600 integrated system, an instrument related issue cannot be completely ruled out as a contributor to the event.The customer appeared to store and handle the biorad qcs correctly, therefore improper storage and handling of the biorad qcs did not likely contribute to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected intact pth (ipth) results were obtained when a non-vitros, biorad, qc fluid was tested using vitros ipth lot 2030 on a vitros xt 7600 integrated system.Biorad lot 65001 (level 1) results of 33.40, 31.78, 29.45 28.80 and 28.33 pg/ml versus the baseline mean value of 20.54 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 results were obtained when the customer was processing a non-patient fluid.There has been no 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: 21761219
• Report Number: 3007111389-2025-00036
• Device Sequence Number: 12951514
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: (01)10758750006267(17)250428(11)240724(10)2030
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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: 04/28/2025
• Device Catalogue Number: 6802892
• Device Lot Number: 2030
• 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: 03/10/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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