MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6802892
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
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 have occurred with multiple patient samples, tested on a vitro 5600 integrated system, when comparing data from a method comparison study between vitros ipth results and a non-vitros siemens system.In addition, both higher and lower than expected vitros ipth results were obtained from two levels of non-vitros biorad specialty immunoassay controls, lot 64960 when compared to the respective vitros peer mean.Finally, either higher or lower than expected results were obtained from a single level of randox immunoassay premium plus control, lot 2219ec, where the expected value was unknown.Correlation patient sample 1 vitros ipth serum result of 91.2 pg/ml vs.The siemens result of 57.2 pg/ml.Correlation patient sample 2 vitros ipth plasma result of 131.6 pg/ml and the vitros ipth serum result of 155.1 pg/ml vs.The siemens result of 69.7 pg/ml.Correlation patient sample 3 vitros ipth plasma result of 109.1 pg/ml and the vitros ipth serum result of 105.2 pg/ml vs.The siemens result of 55.8 pg/ml.Correlation patient sample 4 vitros ipth plasma result of 199.1 pg/ml and the vitros ipth serum result of 187.8 pg/ml vs.The siemens result of 114.4 pg/ml.Correlation sample 5 vitros ipth plasma result of 89.7 pg/ml and the vitros ipth serum result of 77.2 pg/ml vs.The siemens result of 48.7 pg/ml.Correlation patient sample 6 vitros ipth plasma result of 117.0 pg/ml and the vitros ipth serum result of 103.8 pg/ml vs.The siemens result of 57.5 pg/ml.Biorad level 2 vitros ipth results of 105.6, 106.1, 107.9, 327.1, 329.4 and 891.8 pg/ml vs.The vitros peer mean value of 185.0 pg/ml.Biorad level 3 vitros ipth results of 273.5, 823.5 and 774.3 pg/ml vs.The vitros peer mean value of 580.7 pg/ml.Randox level 1 vitros ipth results of 94.0, 48.1, 33.1, 33.2, 326.4, 315.6, 324.5 and 321.9 pg/ml vs.An unknown expected result.The magnitude of the bias is significant enough to constitute a reportable event.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The customer did not report the higher than expected patient sample results from the laboratory and there was no allegation of patient harm as a result of this event.This report is number five of five mdrs for this event.Five 3500a forms are being submitted for this event as five devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that higher and lower than expected vitros ipth results have occurred with multiple patient and control samples when testing on a vitro 5600 integrated system.The assignable cause could not be determined with the limited information provided.No diagnostic within-run precision testing was performed that would assess the performance of the vitros 5600 integrated system, therefore, an instrument related performance issue cannot be ruled out as contributing to the event.An ortho field engineer went on site and performed an incubator decontamination procedure and post-service within-run precision testing was within precision limits but were inaccurate with results being outside of the package insert range.A reagent related issue cannot be ruled out as contributing to the event as historical quality control results were inaccurate and imprecise.Quality control results will continue to be monitored to determine if the issue was resolved by the incubator decontamination procedure.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ipth reagent lot 1881.User error cannot be ruled out as contributing to the event.A review of vitros ipth results in e-connectivity determined that the weekly maintenance procedure of processing a vitros maintenance pack for a cleaning cycle had not been performed and the higher than expected vitros ipth results were obtained when the weekly maintenance procedure was expired.The dates the samples were tested on the siemens method were not provided.The length of storage times and storage conditions between testing with the vitros method and siemens method was also not provided.It is possible that fragmentation of the ipth in the samples between test events caused the non-vitros results to be lower than the vitros results, however, this could not be confirmed.

• 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: 19260395
• Report Number: 3007111389-2024-00103
• Device Sequence Number: 6614399
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: 10758750006267
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/06/2024

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: 07/29/2024
• Device Catalogue Number: 6802892
• Device Lot Number: 1881
• 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: 04/09/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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