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

Catalog Number 8298671

Device Problems Use of Incorrect Control/Treatment Settings (1126); High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that twenty higher than expected vitros phyt results were obtained from a non-vitros and a vitros quality control samples using a vitros 5600 integrated system.The assignable cause for the event is an unknown issue with vitros gen 16, coating 0165 slides.Two different vitros phyt slide lots of ctg.0165 were affected.Acceptable performance was obtained using vitros phyt slides from a different coating.Based on acceptable vitros dgxn within-run precision test, there was no indication the vitros 5600 malfunctioned.

Event Description

The customer obtained higher than expected phyt quality control results using a vitros 5600 integrated system across two different reagent lots (units are ¿g/ml): phyt reagent lot 2616-0165-5611.Biorad l3 lot 40930 results of 29.40, 28.50, 29.07, 27.70, 27.84, 28.95 and 27.17 ¿g/ml versus the expected value result of 22.59 ¿g/ml.Vitros pv ii lot x5905 results of 27.7, 27.8 and 30.5 ¿g/ml versus the expected value result of 23.0 ¿g/ml.Phyt reagent lot 2616-0165-7222.Biorad l3 lot 40930 results of 28.23, 27.74 and 28.34 ¿g/ml versus the expected value result of 22.59 ¿g/ml.Vitros pv ii lot x5905 results of 27.6, 28.1, 28.6, 28.7, 27.6 and 28.1 ¿g/ml versus the expected value result of 23.0 ¿g/ml.Biased results of the direction and magnitude observed could lead to inappropriate physician action.There was no report that patient samples were affected and no allegation of patient harm as a cause of this event.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected.This report is number sixteen(16) of twenty (20) emdr¿s for this event.Twenty 3500a forms are being submitted for this event as twenty devices were involved.(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.

Event Description

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

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT REAGENT SLIDES
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 7318990
• MDR Text Key: 102080008
• Report Number: 1319809-2018-00037
• 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: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2018
• Device Catalogue Number: 8298671
• Device Lot Number: 2616-0165-7222
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1