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	05/29/2024
Type of Reportable Event	Malfunction
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) result was obtained from an american proficiency institute (api) proficiency sample when tested on a vitros xt7600 integrated system in conjunction with a vitros ipth reagent.Api sample ias-08 result of 290.7 pg/ml versus the expected result of 214.82 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 obtained was from a non-patient fluid and was reported to the proficiency scheme provider.There was 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).
Additional Manufacturer Narrative
The investigation determined that a higher-than-expected vitros intact pth (ipth) result was obtained from an american proficiency institute (api) proficiency sample when tested on a vitros xt7600 integrated system in conjunction with a vitros ipth reagent.A definitive assignable cause for the higher-than-expected vitros result could not be determined.Historical qc results leading up to the 29 may 2024 api test event indicates the vitros ipth reagent lot 1885 was performing as intended with regards to accuracy and precision.The cause of the issue with the initial testing of the api sample in (b)(6) 2024 remains unknown.The 30 other vitros users in the program all returned acceptable results for the sample in question, ruling out the likelihood of a sample specific issue.Additionally, repeat testing of the discordant sample by the customer returned a result within the api expected range for that sample.There is also no indication of any instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, as precision testing was not performed at the time of the event, an instrument issue cannot be completely ruled out as 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 1885.

• 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: 19927430
• Report Number: 3007111389-2024-00150
• Device Sequence Number: 16843513
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: (01)10758750006267(17)240729(11)231127(10)1885
• 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): 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: 07/29/2024
• Device Catalogue Number: 6802892
• Device Lot Number: 1885
• 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: 07/12/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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