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

Catalog Number 6802892

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros intact pth (ipth) results were obtained from multiple samples from a single patient processed using vitros immunodiagnostic products intact pth reagent lot 1820 on a vitros 5600 integrated system.The results were higher than expected when compared to the initial results for the patient.Patient sample results of 184.32 and 165.56 pg/ml vs an expected result of 81.95 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros ipth results were reported out of the laboratory.Physicians questioned the results and no treatment was initiated, altered or stopped based on the reported results.There has been no reported 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 604700.

Manufacturer Narrative

The investigation has determined that higher than expected vitros intact pth (ipth) results were obtained from multiple samples from a single patient processed using vitros immunodiagnostic products intact pth reagent lot 1820 on a vitros 5600 integrated system.The results were higher than expected when compared to the initial results for the patient.A definitive assignable cause could not be determined.The customer made no suggestion of any issues with the quality control fluids processed at the customer site and no issues regarding accuracy or precision of the vitros assay were indicated.As precision testing was not performed on the vitros 5600 system, no assessment of the instrument¿s performance at the time of the event was made.However, the customer gave no indication of any vitros 5600 system malfunction.Additionally, according to the customer, the results were reproducible for the patient samples.Therefore, an instrument issue is not a likely contributor to the event.Pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.In addition, a pre-analytical sample mix-up could not be entirely ruled out as a contributor 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 1820.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
• Type of Device: 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18523958
• MDR Text Key: 333514040
• Report Number: 3007111389-2024-00012
• Device Sequence Number: 1
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: 10758750006267
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2024
• Device Catalogue Number: 6802892
• Device Lot Number: 1820
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1