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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros ipth results have occurred with two different correlation samples when comparing results obtained from serum and plasma samples collected from the same patients.The samples were tested on the same vitros 5600 integrated system.The assignable cause could not be determined with the information provided.The majority of the samples in the repeat test event were tested 1 - 2 hours after the initial test event.The storage conditions between test events were not provided.In both events, the samples that were tested later had lower than expected results, regardless of whether the samples were serum or plasma.The special precautions sections of the vitros ipth ifu states: "intact pth is labile and susceptible to fragmentation.Correct handling of patient samples is necessary to ensure that the pth molecule remains intact.The degree of fragmentation will depend on both time and temperature of storage." it is possible that fragmentation of the ipth in the samples prior to being tested with the later test event caused those vitros ipth results to be lower than the vitros ipth results obtained from the initial test event.However, this could not be confirmed.Quality control results obtained within the timeframe of the event were acceptable, therefore, a performance issue with vitros ipth reagent lot 2110 did not likely contribute to the event.There is no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, it cannot be completely ruled out as diagnostic within run precising testing was not performed at the time of the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ipth lot 2110.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros ipth results have occurred with two different correlation samples when comparing results obtained from serum and plasma samples collected from the same patients.The samples were tested on the same vitros 5600 integrated system.Correlation sample 4 plasma sample vitros ipth result of 30.9 pg/ml vs.The correlation sample 4 serum sample vitros ipth result of 61.3 pg/ml.Correlation sample 14 serum sample vitros ipth result of 32.9 pg/ml vs.The correlation sample 14 plasma sample vitros ipth result of 48.7 pg/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros ipth results were not reported from the laboratory and there was no allegation of patient harm.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 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: 22381715
• Report Number: 3007111389-2025-00078
• Device Sequence Number: 15848665
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: (01)10758750006267(17)251124(11)250218(10)2110
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: 11/24/2025
• Device Catalogue Number: 6802892
• Device Lot Number: 2110
• 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: 06/11/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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