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	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected intact pth (ipth) results were obtained when samples from multiple patients were tested using vitros ipth lot 1980 on a vitros xt 7600 integrated system.The results were higher than expected when compared to roche pth results for the same patient samples.Patient 1, vitros ipth result of 100.57 pg/ml versus the roche pth result of 65.9 pg/ml patient 2, vitros ipth results of 96.00, 74.44 and 86.04.Pg/ml versus the roche pth result of 63.2 pg/ml patient 3, vitros ipth result of 129.79.Pg/ml versus the roche pth result of 79.9 pg/ml patient 4, vitros ipth result of 135.00.Pg/ml versus the roche pth result of 93.2 pg/ml patient 5, vitros ipth result of 109.86.Pg/ml versus the roche pth result of 69.5 pg/ml patient 6, vitros ipth result of 80.48.Pg/ml versus the roche pth result of 52.7 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 reported from the laboratory.However, no treatment was altered, initiated or stopped based on the reported results and corrected reports documenting the roche results were later issued.There has been no allegation of patient harm as a result of this event.This report is number one 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 606932.
Additional Manufacturer Narrative
The investigation determined that higher than expected intact pth (ipth) results were obtained when samples from multiple patients were tested using vitros ipth lot 1980 on a vitros xt 7600 integrated system.The results were higher than expected when compared to roche pth results for the same patient samples.A definitive cause of the event was not established.Historical qc results from biorad qc testing indicate acceptable vitros ipth lot 1980 performance.Additionally, vitros ipth lot 1980 performance was deemed acceptable from vitros ipth control testing and ongoing tracking and trending did not identify any signals to suggest there is a systemic quality issue with vitros ipth lot 1980.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 xt7600 integrated system, an instrument related issue cannot be completely ruled out as a contributor to the event.Improper storage and handling of the patient samples cannot be ruled out as a contributor to the event.Roche pth testing occurred up to two days following vitros ipth testing for the patients and as ipth is susceptible to fragmentation, it is possible the time between testing events contributed to the discordance observed between the vitros ipth and roche pth methods and that the higher vitros ipth results for the patients were accurate, however, this could not be confirmed.Method to method differences between the vitros ipth and roche pth methods cannot be ruled out as a contributor to the event as the methods for ipth testing are not standardized, therefore numerical variation can be seen between methods.Ortho issued customer letters (cl2016-196, 05 october 2016 and cl2016-220, 24 november 2016) indicating that the results observed for patient samples on the vitros ipth assay were high when compared to alternate methods and that an atypical number of samples were predicting above the reference interval.

• 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: 19932953
• Report Number: 3007111389-2024-00153
• Device Sequence Number: 14148563
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: (01)10758750006267(17)250120(11)240413(10)1980
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/07/2024

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: 01/20/2025
• Device Catalogue Number: 6802892
• Device Lot Number: 1980
• 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: 07/15/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2024
• 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