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	04/21/2026
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 ipth ii (ipth2) results were obtained from non-vitros biorad quality controls and vitros ipth ii quality controls processed using vitros immunodiagnostic products intact pth ii reagent lot 0270 on a vitros 5600 integrated system.Biorad lot 1003750 l1 result of 30.03 pg/ml vs an expected result of 21.4 pg/ml biorad lot 1003750 l3 result of 581.6 pg/ml vs an expected result of 420.0 pg/ml vitros ipth ii control lot 0190 l1 results of 42.6, 42.93, 43.06, 43.45 and 43.20 pg/ml vs an expected result of 30.7 pg/ml vitros ipth ii control lot 0190 l2 results of 147.28, 147.08, 148.55, 148.23 and 148.39 pg/ml vs an expected result of 108.5 pg/ml vitros ipth ii control lot 0190 l3 results of 705.55, 724.13, 724.99, 715.41 and 712.13 pg/ml vs an expected result of 521.8 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 ipth2 results were from quality control fluids and no results were reported from the laboratory.However, the investigation cannot conclude that patient sample results were not or would not be affected if the event were to recur undetected.There have been no allegations 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 has determined that higher than expected vitros ipth ii (ipth2) results were obtained from non-vitros biorad quality controls and vitros ipth ii quality controls processed using vitros immunodiagnostic products intact pth ii reagent lot 0270 on a vitros 5600 integrated system.A definitive assignable cause of the event could not be determined with the information provided.The customer is not currently connected to e-connectivity, therefore, the investigation was limited to the information provided by the customer.No historical quality control results from vitros ipth2 lot 0270 were provided upon request.Therefore, a reagent related issue cannot be ruled out as contributing factor of the event.A suboptimal calibration cannot be ruled out as a contributing factor of the event as the customer did not provide the calibration parameters for vitros ipth2 lot 0270.Additionally, after the customer calibrated an alternate lot of vitros ipth2 reagent on the instrument, results returned to expectations.In addition, the customer had replaced the well wash aspirate filters on the vitros 5600 system prior to calibrating the alternate lot of vitros ipth2 reagent.Therefore, an instrument related issue cannot be ruled out as a contributor to the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ipth2 reagent lot 0270.

• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 25149203
• Report Number: 3007111389-2026-00096
• Device Sequence Number: 18829338
• Product Code: CEW
• UDI-Device Identifier: 10758750032709
• UDI-Public: (01)10758750032709(17)260601(11)250828(10)0270
• 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): 05/12/2026

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: 06/01/2026
• Device Catalogue Number: 6900052
• Device Lot Number: 0270
• 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: 04/21/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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