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

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 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected phyt results were obtained when processing a quality control sample and two patient samples using two different vitros phyt slide lots on a vitros 4600 system.A definitive assignable cause could not be determined.The most likely assignable cause of the higher than expected vitros phyt results, when processing the two patient samples following the calibration of vitros phyt slide lot 2616-0166-7652, is a sub-optimal calibration.The most likely assignable cause for the higher than expected quality control result, is an issue with vitros phyt lot 2616-0165-6787.Ortho has opened an investigation to investigate an increase in imprecision for reagent lots from coating 0165.The performance of the instrument can be ruled out as a contributor to the event as acceptable within cart precision testing was obtained both before and after service.

Event Description

A customer obtained imprecise vitros phyt results when processing a quality control fluid and higher than expected vitros phyt results when processing two patient samples using a second vitros phyt slide lot on a vitros 4600 chemistry system.(b)(6).A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected.The higher than expected vitros phyt results were obtained during a patient correlation and were not reported outside of the laboratory.There were no reported allegations of patient harm as a result of the event; however the investigation cannot conclude patient results would not be affected if the event were to recur undetected.(b)(4).This report is number two of three mdr's for this event.Three 3500a forms are being submitted for this event as three devices were involved.

Event Description

This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

Manufacturer Narrative

A potential issue related to the absolute response rates and the dose response curve of phyt coating 0165 is being investigated.The fda¿s new york district office was notified of this issue on 16 may 2018.Please refer to report # 1319809-05/18/2018-001.

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT SLIDES
• Type of Device: IN VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 7491604
• MDR Text Key: 108148943
• Report Number: 1319809-2018-00074
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Catalogue Number: 8298671
• Device Lot Number: 2616-0166-7652
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1