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

Catalog Number 6802892

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that imprecise vitros intact pth (ipth) results were obtained when non-vitros mas quality control (qc) fluids were processed using vitros ipth reagent lot 1805 when tested on a vitros xt7600 integrated system.A definitive assignable cause for the imprecise vitros ipth results could not be determined.Based on historical quality control results, a vitros ipth lot 1805 reagent issue cannot be completely ruled out as a contributor to the event.Additionally, there are also no indications of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, the customer did not perform an appropriate within run precision test at the time of the event to definitively rule out an instrument issue.Handling and processing of the mas qc samples could not be ruled out as a contributing factor due to inconsistency between the mas omni-immune instructions for use (ifu) and the vitros ipth ifu with regards processing the fluids, although this was not be confirmed.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth reagent lot 1805.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower and higher vitros intact pth (ipth) results were obtained when non-vitros mas quality control (qc) fluids were processed using vitros ipth reagent lot 1805 when tested on a vitros xt7600 integrated system.Mas omniimmune oim24113a level 3 result of 81.82 pmol/l versus the expected result of 124.49 pmol/l mas omniimmune oim27033 level 3 result of 158.66 pmol/l versus the expected result of 120.565 pmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower and higher vitros ipth results obtained were from non-patient fluids and were not reported outside of the laboratory.Ortho is not aware of any reported allegation of patient harm as a result of this event.This report is number one of two mdr¿s 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 number (b)(4) and reportability assessment (b)(6).

• 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: 18144172
• MDR Text Key: 328203865
• Report Number: 3007111389-2023-00198
• Device Sequence Number: 1
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: 10758750006267
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2024
• Device Catalogue Number: 6802892
• Device Lot Number: 1805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1