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

Model Number 6802892

Device Problem High Test Results (2457)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a higher than expected vitros ipth result was obtained from a single patient processed using vitros immunodiagnostic products intact pth reagent lot 1851 on a vitros xt 7600 integrated system.The result was higher than expected when compared to the results obtained for the patient when tested on a roche cobas analyzer.The assignable cause for the higher than expected vitros ipth result was the presence of heterophilic antibodies in the patients sample that are interfering with the vitros ipth assay.Per the vitros ipth instructions for use, limitations of the procedure: heterophilic antibodies in serum or plasma samples may cause interference with immunoassays.Based on acceptable historical quality control results, a vitros ipth reagent performance issue is not a likely contributor to the event.The customer declined to perform any precision testing on the vitros xt 7600 system and gave no indication of any vitros xt 7600 system malfunction.Continual tracking and trending does not indicate a systemic issue with vitros ipth lot 1851.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros ipth result was obtained from a single patient processed using vitros immunodiagnostic products intact pth reagent lot 1851 on a vitros xt7600 integrated system.The result was higher than expected when compared to the results obtained for the patient when tested on a roche cobas analyzer.Vitros patient sample result of 1012 pg/ml vs the roche cobas result of 34 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The vitros ipth result of 1012 pg/ml was reported from the laboratory.No corrected report issued and no treatment was stopped/started/altered based on the higher than expected result.There was no 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 (b)(4).

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18706054
• MDR Text Key: 336286517
• Report Number: 3007111389-2024-00026
• Device Sequence Number: 1
• Product Code: CEW
• 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: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6802892
• Device Catalogue Number: 6802892
• Device Lot Number: 1851
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1