MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CREA SLIDES; IN-VITRO DIAGNOSTIC

Catalog Number 6802584

Device Problem Insufficient Information (3190)

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

Event Date 02/20/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros crea results were obtained from multiple patient samples from multiple patients using vitros chemistry products crea slides on a vitros 350 chemistry system.The results were lower than expected when compared to an alternate method, siemens dimension, as well as historical results for the patients.The most likely cause of the lower than expected vitros crea patient sample results is an interferent in the samples that affects the vitros crea assay.The patients were taking several medications and vitamins at the time of the event.As vitros crea lot 1536-3508-4450 was a new lot put into use around the time of the event, there were not enough historical quality control (qc) results available to adequately evaluate the performance of the vitros crea reagent.Therefore, an issue related to the performance of the vitros crea reagent could not be ruled out as a contributor of the event.However, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros crea reagent lot 1536-3508-4450.Within run precision testing was not performed on the vitros 350 chemistry system.Performance of the instrument did not change after service actions were performed on the instrument which included cleaning, adjustments and parts replacement.Therefore, an instrument related issue could not be confirmed nor ruled out as a contributor of the event.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the 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 method to method difference related issue between the vitros crea assay and the siemens dimension method could not be confirmed nor ruled out as a contributing factor of the event.A definitive assignable cause could not be determined with the information provided.(b)(4).

Event Description

A customer obtained lower than expected vitros crea results from multiple patient samples from multiple patients using vitros chemistry products crea slides on a vitros 350 chemistry system when compared to an alternate method, siemens dimension, as well as historical results for the patients.(b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected.The lower than expected vitros crea results were reported outside of the laboratory.However, physicians questioned the results, and no treatment was initiated, altered or stopped based on the lower than expected results.There was no allegation of actual patient harm as a result of this event.This report is number one of five mdr¿s for this event.Five 3500a forms are being submitted for this event as five devices were involved.This report corresponds to ortho clinical diagnostics (ortho) inc.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 11503803
• MDR Text Key: 280453412
• Report Number: 1319809-2021-00016
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 6802584
• Device Lot Number: 1536-3508-4450
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1