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	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros intact pth (ipth) results were obtained from a non-vitros biorad quality control (qc) fluid and patient samples when tested on two different vitros 5600 integrated system in conjunction with a vitros ipth reagent.Biorad level 1 lot 64990 results of 28.51, 28.74, 28.87, 28.70, 29.17 and 28.72 pg/ml versus the expected result of 21.89 pg/ml patient sample (b)(6) result of 226.9 pg/ml versus the expected result of 142.2 pg/ml patient sample (b)(6) result of 24.91 pg/ml versus the expected result of 19.1 pg/ml 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 obtained from a biorad qc fluid and when performing a patient sample correlation exercise and were not reported from the laboratory.Ortho has not been made aware of any 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 numbers (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros intact pth (ipth) results were obtained from a non-vitros biorad quality control (qc) fluid and patient samples when tested on two different vitros 5600 integrated system in conjunction with a vitros ipth reagent.A definitive assignable cause for the higher than expected vitros results could not be determined.Based on limited biorad quality control results, a vitros ipth lot 2000 reagent issue cannot be completely ruled out as a contributor to the event.However, when using the vitros ipth qc fluids on both instruments, acceptable accuracy was obtained.Therefore, an unknown issue with the biorad specialty immunoassay quality control (qc) fluids, lot 64990 cannot be ruled out as contributing to this event.Additionally, there are also no indications of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, the customer did not perform a within run precision test at the time of the event to definitively rule out an instrument issue.Furthermore, the age and storage of the patient samples used in the correlation testing performed by the customer cannot be ruled out as possibly contributing to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth reagent lot 2000.

• 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: 20231326
• Report Number: 3007111389-2024-00184
• Device Sequence Number: 15582657
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: (01)10758750006267(17)250303(11)240529(10)2000
• 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): 09/16/2024

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: 03/03/2025
• Device Catalogue Number: 6802892
• Device Lot Number: 2000
• 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: 08/20/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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