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

Catalog Number 8298671

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected phyt results were obtained from biorad level 3 (lot 40903) quality control fluid using vitros phenytoin (phyt) reagent on a vitros 350 chemistry system.The assignable cause could not be determined.The biorad historical quality control results indicate an accuracy issue isolated to the biorad level 3 control fluid as the vitros tdm pviii results obtained using the same vitros phyt lot in combination with the vitros 350 system were acceptable.In addition, historical phyt quality control results indicate a within laboratory precision issue when testing both the biorad level 3 and vitros tdm pviii controls.An analyzer related issue and a control fluid handling issue cannot be ruled out as potential contributors to the event.

Event Description

The investigation determined that higher than expected phyt results (26.58, 26.18 ug/ml versus expected 21.36 ug/ml) were obtained from biorad level 3 (lot 40903) quality control fluid using vitros phenytoin (phyt) reagent on a vitros 350 chemistry system.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The unexpected vitros phyt results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the event.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number 1894687 / ivd 405843.

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT SLIDES
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 6651917
• MDR Text Key: 78094859
• Report Number: 1319809-2017-00094
• Device Sequence Number: 1
• Product Code: DIP
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 8298671
• Device Lot Number: 2614-0162-7405
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1