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

Catalog Number 1726926

Device Problem Low Test Results (2458)

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

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that imprecise, lower than expected vitros amon results were obtained from a vitros liquid performance verifier (lot c5707) using vitros amon slides (lot 1017-0247-4591) when tested on a vitros 5,1 fs chemistry system.The definitive assignable cause could not be determined.The likely cause of the imprecise, lower than expected vitros amon results is an analyzer related issue caused by microslide incubator contamination.However, without unacceptable amon precision test results prior to the customer cleaning the microslide incubator this could not be confirmed.Historical quality control results were not available to evaluate vitros amon lot 1017-0247-4591 performance.Therefore an issue with vitros amon lot 1017-0247-4591 could not be confirmed or ruled out as a contributor of the event.Additionally, ongoing tracking and trending has not identified signals that indicate an issue with vitros chemistry products amon slides lot 1017-0247-4591.The assignable cause of this event is unknown.

Event Description

A customer obtained imprecise, lower than expected vitros ammonia (amon) results from a vitros liquid performance verifier using vitros amon slides (lot 1017-0247-4591) when tested on a vitros 5,1 fs chemistry system.Vitros liquid performance verifier ii lot c5707 - vitros amon results 114.34 and 142.17 umol/l versus midpoint of rom 194.5 umol/l 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 as a result of this event.However the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no reported allegation of actual patient harm as a result of this event.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 7756170
• MDR Text Key: 116913283
• Report Number: 1319809-2018-00102
• Device Sequence Number: 1
• Product Code: JID
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: 1726926
• Device Lot Number: 1017-0247-4591
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2017
• 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