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 Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that non-reproducible vitros phenytoin (phyt) results were obtained on one level of quality control fluid processed using the vitros 5600 integrated system.The investigation could not determine the assignable cause.The issue was isolated to one day of quality control testing and an undefined transient issue is a likely contributor to the event.Additionally, pre-analytical sample handling could not be ruled out as a contributing factor.Based on historical quality control data, a vitros phyt reagent issue has been ruled out as a contributing factor to the event.There was no indication of a vitros instrument malfunction.

Event Description

The customer obtained non-reproducible vitros phenytoin (phyt) quality control results from one level of control (tdm l3= 20.78, 20.76, >40, >40 versus expected 28.3 ug/ml) processed using the vitros 5600 integrated system.The unexpected vitros phyt results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the event.This report is number 2 of 4 mdr¿s for this event.Four (4) 3500a forms are being submitted for this event as 4 devices were involved.(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
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 6421141
• MDR Text Key: 70758941
• Report Number: 1319809-2017-00023
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2017
• Device Catalogue Number: 8298671
• Device Lot Number: 2614-0162-8097
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1