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

Catalog Number 8298671

Device Problem Low Test Results (2458)

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

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected, vitros phyt results were obtained when processing a single non-vitros biorad l1 control fluid and vitros tdm performance verifier iii on a vitros 350 chemistry system.A definitive assignable cause could not be determined.The assignable cause of the event is an unknown issue with vitros gen 16, coating 0165 slides.Improved vitros phyt performance was obtained using gen 15, coating 0166 slides.Based on an acceptable vitros dgxn within-run precision test, there was no indication the vitros 350 system malfunctioned.

Event Description

A customer obtained lower than expected vitros phyt results when processing a single non-vitros biorad l1 control fluid and vitros tdm performance verifier iii on a vitros 350 chemistry system.Vitros tdm performance verifier iii lot p5703 results 22.3, 22.6 ug/ml versus the midpoint of the range of means (rom) 28.6 ug/ml.Biorad lot 15951 vitros phyt result 2.39 ug/ml versus established mean 4.6 ug/ml a biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected.The lower than expected, vitros phyt results were obtained when processing quality control fluids.However, the investigation could not conclude that patient samples were not, or would not be affected if the event were to recur undetected.Ortho was not made aware of any patient harm.This report corresponds to ortho clinical diagnostics inc.Complaint number (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 VITROS DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 7428329
• MDR Text Key: 105897182
• Report Number: 1319809-2018-00065
• 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: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Catalogue Number: 8298671
• Device Lot Number: 2616-0165-6832
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1