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

Catalog Number 6192255

Device Problem Low Test Results (2458)

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected nt ¿ probnp ii (ntbnp ii) results were obtained when processing a non-vitros mas cardio-immune quality control (qc) fluid lot oim2503 on a vitros 5600 integrated system.The cause of the lower than expected vitros ntbnp ii qc sample results could not be determined.The qc review indicates there was within laboratory accuracy and precision issues with the customers level 1 qc fluid over the timeframe reviewed using vitros ntbnp ii lot 0160.There is no package insert (pi) data or peer data available for the vitros ntbnp ii to compare the customers qc results or the customers baseline data.It is not known how the customer obtains their baseline mean/sd data.No information was provided with regards to how the qc samples were handled prior to processing, therefore, it is possible that improper pre-analytical qc handling contributed to this event, however, this cannot be confirmed.The customer stated that the non-vitros mas qc fluids are stored refrigerated and are left to reach room temperature before use, however, no information was provided with regards to how long the vials had been reconstituted and how long the qcs were left to reach room temperature before processing, therefore, it is possible that improper pre-analytical qc handling contributed to this event, however, this cannot be confirmed.Within run vitros tsh precision testing carried out indicated acceptable instrument performance on 22 september 2023, however, no precision testing was carried out around the time of the events (25 august 2023, 17 september 2023 and 18 september 2023), therefore, an instrument issue cannot be entirely ruled out as a contributing factor.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ntbnp ii reagent lot 0160.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected nt ¿ probnp ii (ntbnp ii) results were obtained when processing a non-vitros mas cardio-immune quality control (qc) fluid lot oim2503 on a vitros 5600 integrated system.Mas qc level 2 results of 307, 310.32, 312.70, 317.51 and 320.22 pg/ml vs expected result of 428 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 ntbnp ii results were obtained when processing non-patient fluid.The customer made no indication that any patient sample results had been affected.There were no reported allegations of 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)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II 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: 17916042
• MDR Text Key: 326257188
• Report Number: 3007111389-2023-00180
• Device Sequence Number: 1
• Product Code: NBC
• UDI-Device Identifier: 10758750002061
• UDI-Public: 10758750002061
• 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: 10/11/2023

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: 12/12/2023
• Device Catalogue Number: 6192255
• Device Lot Number: 0160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1