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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower than expected intact pth ii (ipth ii) result was obtained when a level 2 biorad qc was tested using vitros ipth ii lot 0145 on a vitros 5600 integrated system.A definitive cause of the event was not established.Historical qc results leading up to the event and qc results following the event indicate acceptable vitros ipth ii lot 0145 performance.Additionally, ongoing tracking and trending did not identify any signals to suggest there is a systemic quality issue with vitros ipth ii lot 0145.An instrument issue cannot be completely ruled out as a contributor to the event, as no within run diagnostic precision testing was conducted around the time of the event to verify the performance of the vitros 5600 integrated system.Precision testing following the event indicated acceptable instrument performance.No information was provided in relation to the handling of the biorad level 2 qc on the date of the event.It is possible improper handling or storage of the level 2 biorad qc contributed to the event, however this could not be confirmed.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower-than-expected intact pth ii (ipth ii) result was obtained when a level 2 biorad qc was tested using vitros ipth ii lot 0145 on a vitros 5600 integrated system.Biorad level 2 (lot 64992) result of 89.14 pg/ml versus the pi mean result of 130 pg/ml biased results of the magnitude and direction observed may led to inappropriate physician action if they were to occur undetected on patient samples.The lower-than-expected vitros ipth ii result was obtained when the customer was processing a non-patient fluid.There has been no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) (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: 21937980
• Report Number: 3007111389-2025-00050
• Device Sequence Number: 18102259
• Product Code: CEW
• UDI-Device Identifier: 10758750032709
• UDI-Public: (01)10758750032709(17)250811(11)241104(10)0145
• Combination Product (Y/N): N
• 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): 04/30/2025

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: 08/11/2025
• Device Catalogue Number: 6900052
• Device Lot Number: 0145
• 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: 04/03/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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