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

Catalog Number 8298671

Device Problem Low Test Results (2458)

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

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that imprecise vitros phyt results were observed from a vitros tdm iii quality control fluid lot p5703 when tested on a vitros 350 chemistry system.A definitive assignable cause could not be determined.A reagent issue, a quality control fluid issue, or a sub-optimal calibration event cannot be ruled out as contributing factors.The issue was resolved when an alternate phyt reagent lot was calibrated and tested using an alternate lot of vitros tdm quality control fluid.An instrument issue can be ruled out as a contributing factor as the instrument performance was within expectations.The customer made no allegations that patient samples were affected and there were no reported allegations of actual patient harm as a result of this event.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.

Event Description

A customer observed imprecise vitros phenytoin (phyt) results using vitros tdm quality control fluid lot p5703 when tested on a vitros 350 chemistry system and the following two lower than expected results were observed.Vitros tdm iii p5703 phyt results of 22.9 and 23.2 ug/ml versus the customer¿s baseline mean of 29.67 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The customer made no allegations that patient samples were affected and there were no reported allegations of actual patient harm as a result of this event.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two 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 (ortho) inc.Complaint numbers: (b)(4).

• 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: 7357011
• MDR Text Key: 103408763
• Report Number: 1319809-2018-00051
• 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: 03/21/2018
• 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: 2616-0165-6787
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1