MAUDE Adverse Event Report: ALLSCRIPTS HEALTHCARE SOLUTIONS; ALLSCRIPTS LAB

Model Number VERSION 16.0.0

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abnormal Blood Gases (1034); Patient Problem/Medical Problem (2688)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Allscripts lab is a software tool that helps manage laboratory operations and workflow.It is intended to store, retrieve, and process laboratory data for clinical use.Allscripts lab automates the processes in the laboratory that support clinical test reporting to assist in delivering patient care.Customers build rules for allscripts lab to transmit test labels on combined orders to multiple printers.When orders are combined, priority and collection route rule logic is interpreted by allscripts lab.The issue is with the logic interpretation, in intermittent cases, that causes the test labels to print to only one printer even when the customer intends to print test labels to more than one printer.Printed test labels are only one indicator that a test order is open and requires lab attention.Customers who encounter this intermittent issue, when results are time critical, have inter-lab notifications and open order displays in the lab to mitigate pt test result delays.Only when these mitigating factors are unattended, would it result in the possibility of transient or minor temporary complaints and that likelihood is deemed to be less than remote.Allscripts lab is investigating those intermittent situations when test labels are not sent to intended printers.There have been no adverse events or patient injuries resultant from the malfunction.

Event Description

Allscripts lab is a software tool that helps manage laboratory operations and workflow.It is intended to store, retrieve, and process laboratory data for clinical use.Allscripts lab automates the processes in the laboratory that support clinical test reporting to assist in delivering patient care.An allscripts lab 16.0.0 customer reported that all test labels for a combined multi-lab er pt order unexpectedly printed to its respiratory lab (rl) printer.Some of the labels on the pt order were intended to print in the metabolic lab (ml).Rl staff used its rl pt test labels and resulted tests with no issues, then called alert/panic test results to the er.Rl did not notify ml of the additional pt test labels.The ml did not notice unprocessed pt specimens in lab receiving and did not attend to an open order electronic display (not related to the allscripts lab system) in the lab that identified the ml test order as incomplete.In the absence of printed test labels, labs employ contingencies to address pt specimens in receiving, for example lab staff can print on-demand test labels from the allscripts lab system.In this case, no alternate test label contingencies were employed and ml tests were completed after a 2-hour delay after collection, by which time the pt had died.The customer did not report pt treatment delays.The complaint investigation determined that allscripts lab 16.0.0 did not cause or contribute to the patient death.However, out of an abundance of caution, the company is submitting the mdr because a pt death occurred in a facility where the company's product was used.

• Type of Device: ALLSCRIPTS LAB
• Manufacturer (Section D): ALLSCRIPTS HEALTHCARE SOLUTIONS; 5995 windward pkwy; alpharetta GA 30005
• Manufacturer (Section G): ALLSCRIPTS HEALTHCARE SOLUTIONS INC.; 5995 windward pkwy; alpharetta GA 30005
• Manufacturer Contact: louise pearson ; 222 merchandise mart plaza; suite 2024; chicago, IL 60654
• MDR Report Key: 7399654
• MDR Text Key: 104849734
• Report Number: 3003781505-2018-00001
• Device Sequence Number: 1
• Product Code: JQP
• 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,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VERSION 16.0.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• 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
• Patient Outcome(s): Other; Disability
• Patient Age: 32 YR