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

Model Number 6802892

Device Problem Low Test Results (2458)

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

Event Date 04/08/2023

Event Type  malfunction  

Event Description

The investigation determined that lower than expected vitros intact pth (ipth) results were obtained when a non-vitros thermofisher mas omni immune quality control (qc) fluid was tested on two vitros xt 7600 integrated systems.Vitros ipth lot 1750 results: mas lot oim 24111a level 1 results of 12.92 and 16.56 pg/ml versus the expected result (baseline mean) of 25.4 pg/ml mas lot oim 24111a level 2 results of 45.57 and 46 pg/ml versus the expected result (baseline mean) of 76.9 pg/ml mas lot oim 24111a level 3 results of 824 and 908 pg/ml versus the expected result (baseline mean) of 1340 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 lower than expected vitros ipth results obtained were from non-patient fluid 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 numbers (b)(4) and reportability assessment 601883.

Manufacturer Narrative

The investigation determined that lower than expected vitros intact pth (ipth) results were obtained when a non-vitros thermofisher mas omni immune quality control (qc) fluid was tested on two vitros xt 7600 integrated systems.A definitive assignable cause for the discordant lower than expected vitros ipth results could not be determined with the information provided.Based on no historical quality control results performed for vitros ipth lot 1750, a reagent issue cannot be completely ruled out as a contributor to the event as the customer does not run daily quality control.The customer gave no indication of any instrument malfunction, and an unexpected instrument performance is not a likely contributor to the event.However, instrument j1 results were similar to instrument j2 results, therefore, while an instrument performance issue cannot be entirely ruled out, it is an unlikely contributor to the event.The customer did not perform any precision testing on the instruments at the time of the events; so, no assessment of the instrument performance at the time of the events was made.Therefore, it cannot be confirmed if the instruments were performing as intended and unexpected instrument performance cannot be completely ruled out as contributing to the events.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth reagent lot 1750.

• 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: 16994229
• MDR Text Key: 315936192
• Report Number: 3007111389-2023-00079
• 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: 05/24/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Model Number: 6802892
• Device Catalogue Number: 6802892
• Device Lot Number: 1750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1