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	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that higher than expected vitros intact pth (ipth) results obtained from college (b)(6).Proficiency samples when tested using a vitros xt 7600 integrated system.This assignable cause of the event could not be determined.Historical qc fluid performance indicates a vitros ipth lot 2155 performance issue is not a likely contributor to the event.Vitros ipth reagent lot 2161 was a brand-new lot to the customer the day prior to the second phs event (24 march 2026).Post-calibration qc was acceptable, however, given the very low number of data points (n=1), a reagent related issue related to vitros ipth reagent lot 2161 cannot entirely be 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 lots 2155 or 2161.No precision testing was performed on the vitros xt 7600 system to verify instrument performance.However, as qc results were acceptable for vitros ipth reagent lots 2155 and 2161, an instrument related issue is not a likely contributor to the event.It was determined that the customer was following caps recommendations for sample handling and storage throughout this investigation.Therefore, improper sample storage and/or handling are not likely contributors to this event.An ortho service engineer (se) reviewed the complaint on 04 may 2026 and stated that a pipette-reconstitution error is a potential cause of this event, however, as results were consistent across two different fixed volume pipettes for two different cap proficiency survey sample sets, a pipette-driven reconstitution issue is not a likely contributor to the event.
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 obtained from college of american pathologists (cap) proficiency samples when tested using a vitros xt 7600 integrated system.Vitros ipth lot 2155: pth-01 (initial) result of 518.8 pg/ml vs an expected cap mean result of 360.13 pg/ml pth-02 (initial) result of 19.2 pg/ml vs an expected cap mean result of 13.00 pg/ml pth-03 (initial) result of 296.4 pg/ml vs an expected cap mean result of 207.23 pg/ml pth-04 (initial) result of 1,735 pg/ml vs an expected cap mean result of 1,272.47 pg/ml pth-05 (initial) result of 985.7 pg/ml vs an expected cap mean result of 707.56 pg/ml vitros ipth lot 2161: pth-01 (repeat) result of 491.5 pg/ml vs an expected cap mean result of 360.13 pg/ml pth-03 (repeat) result of 272.0 pg/ml vs an expected cap mean result of 207.23 pg/ml pth-04 (repeat) result of 1,696.7 pg/ml vs an expected cap mean result of 1,272.47 pg/ml pth-05 (repeat) result of 965.5 pg/ml vs an expected cap mean result of 707.56 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 results were obtained when the customer was processing non-patient fluids.There has been no allegation of patient harm as a result of this event.This report is number two of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc.(ortho) complaint numbers (b)(4), (b)(4) and reportability assessment (b)(4).

• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 25138853
• Report Number: 3007111389-2026-00095
• Device Sequence Number: 9542818
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: (01)10758750006267(17)260420(11)250716(10)2155
• 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): 05/11/2026

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: 04/20/2026
• Device Catalogue Number: 6802892
• Device Lot Number: 2155
• 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: 04/13/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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