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

Catalog Number 8298671

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros phyt results were obtained from a single non-vitros biorad l2 control fluid using vitros phyt slide lot 2616-0165-6276 on a vitros 5600 integrated system s/n (b)(4).The assignable cause of the event is an unknown issue with vitros gen 16, coating 0165, slides used in vitros phyt lot 2616-0165-6276.There was no indication that the vitros 5600 system malfunctioned as a vitros dgxn within-run precision test was acceptable.Improved vitros phyt performance was obtained using an alternative vitros phyt slide lot.

Event Description

A customer obtained higher than expected vitros phyt results for a non-vitros quality control (qc) fluid, when compared to the customer established mean.The results were generated using vitros chemistry products phyt slides processed on a vitros 5600 integrated system.Non-vitros biorad level 2 lot 31850 results 30.76, 33.08, 31.25 vs.Expected result of 25.52 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected.Ortho was not made aware of any allegation of patient harm due to the event.However the investigation cannot rule out that patient results were not or would not be affected if the event were to recur undetected.(b)(4).This report is number three 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: 7365955
• MDR Text Key: 103698928
• Report Number: 1319809-2018-00055
• 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: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Catalogue Number: 8298671
• Device Lot Number: 2616-0165-6276
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1