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

Catalog Number	6900052
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a higher than expected vitros intact pth ii (ipth ii) quality control (qc) result was obtained when using non-vitros biorad liquichek specialty immunoassay control lot 65000 on a vitros xt 7600 integrated system.The assignable cause of the event could not be determined.Based on historical quality control (qc) results, a vitros ipth ii lot 0190 performance issue is not a likely contributor of the event.No diagnostic precision testing was performed on the vitros xt 7600 system and therefore, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.However, historical qc results were within expectations and there was no evidence of an instrument malfunction.Qc sample handling and storage cannot be ruled out as contributing factors to the event.The customer reported that the biorad qc fluid was thawed, stored in the refrigerator, and allowed to warm to room temperature before testing.Per the liquichek specialty immunoassay control ifu, once thawed and opened, the qc is stable for 30 days for all analytes except intact pth, which is stable for 7 days.Therefore, if the qc fluid had been opened for longer than 7 days, stability of pth may have been compromised, and pre-analytical handling could have contributed to the event, although this cannot be confirmed.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ipth2 lot 0190.
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 ii (ipth ii) quality control (qc) result was obtained when using non-vitros biorad liquichek specialty immunoassay control lot 65000 on a vitros xt 7600 integrated system.Biorad level 3 qc 65000 result of 480.44 pg/ml versus the expected result of 354.00 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 ii result was obtained when the customer was processing non-patient fluids.The customer made no indication that any patient sample results had been affected.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).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH II 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: 22994237
• Report Number: 3007111389-2025-00102
• Device Sequence Number: 9620060
• Product Code: CEW
• UDI-Device Identifier: 10758750032709
• UDI-Public: (01)10758750032709(17)251121(11)250219(10)0190
• 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): 09/08/2025

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: 11/21/2025
• Device Catalogue Number: 6900052
• Device Lot Number: 0190
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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