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

Catalog Number 8298671

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected patient result was obtained for vitros phyt microslides processed using a vitros 5600 integrated system.There was no indication of a vitros 5600 instrument malfunction or a vitros phyt reagent issue.The event was isolated to one patient sample.The most likely cause of the event is a sample related issue due to the observation of debris floating in the sample as well as high turbidity and hemolysis.Per the vitros phyt instructions for use: do not use hemolyzed samples.It is suspected that the sample quality impacted the vitros 5600 system sample metering event causing the low phyt outlier result, although this could not be definitively proven.

Event Description

The customer obtained a lower than expected phenytoin (phyt) patient result (6.46 ¿g/ml versus expected 16.96 ¿g/ml) using vitros phyt microslides on a vitros 5600 integrated system.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected phyt result was obtained from a patient sample while evaluating the assay as part of the installation of the vitros 5600 system.The vitros 5600 system was not yet being used by the customer for routine testing.There was no allegation of patient harm as a result of this event.(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 SLIDES
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 7337480
• MDR Text Key: 103019971
• Report Number: 1319809-2018-00042
• 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: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2018
• Device Catalogue Number: 8298671
• Device Lot Number: 2616-0165-7214
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1