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

Catalog Number 8298671

Device Problem High Test Results (2457)

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

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected phyt results were obtained from a non-vitros biorad level 3 quality control fluid using vitros phenytoin (phyt) reagent on a vitros 5600 integrated system.The higher than phyt expected results were isolated to results obtained from a phyt calibration event where the parameters were suboptimal.The assignable cause of the suboptimal calibration is unknown.User error was a contributing factor as the customer did not respond to the higher than expected quality control results until >1 month after the initial calibration event.The customer was using an alternate phyt lot number for patient testing during that month and only processed quality fluids on the affected phyt lot.Acceptable phyt quality control results were obtained after a recalibration of vitros phyt was completed.

Event Description

The investigation determined that higher than expected vitros phyt results (37.6, 37.0, >40.0 (x10) ug/ml vs.Expected 21.6 ug/ml) were obtained from a single non-vitros biorad level 3 lot 40920 control fluid using vitros phyt slides 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 on patient samples.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 corresponds to ortho clinical diagnostics inc.Complaint number 1961634 / ivd 421111.

• 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: 7128828
• MDR Text Key: 96061792
• Report Number: 1319809-2017-00193
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: 8298671
• Device Lot Number: 2615-0164-3763
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1