MAUDE Adverse Event Report: BECKMAN COULTER, INC. LAB PRO MBT; MICROSCAN WALKAWAY MIDDLEWARE

Device Problems False Device Output (1226); Application Program Problem (2880); Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2016

Event Type  Injury  

Event Description

Beckman coulter has developed a middleware system called lab pro mbt that allows interfacing of a bruker maldi tof ms.Identification to the lab info system.This middleware system falsely categorizes bacterial identifications from the bruker instrument as "acceptable" allowing them to enter the pt record even when the bruker instrument considers the identifications to be "unacceptable." the bruker codes acceptable identifications in green and unacceptable identifications in yellow or red.The lab pro mbt middleware (by backman coulter) changes the yellow, unacceptable identifications to green in the software.The user only knows that the identification is unacceptable if they click on the sample and do further interrogation.Furthermore, the yellow (unacceptable) identifications are not recognized by lab pro mbt as unacceptable and can be directly transmitted into the pt record when using the middleware.In speaking with beckman coulter (on (b)(6) 2016), they are aware of this issue but have been unable to provide info regarding when the issue will be fixed.In addition, although they were aware of the problem per several conversations with employee, beckman coulter did not alert users or attempt to advise them during the installation and/or during subsequent testing of this instrument.Instead, the company waited until we independently identified the problem which placed pts at risk.In conclusion, the current lab pro mbt software design poses a significant and imminent risk to pts.We identified the problem with the lab pro mbt software prior to our first day of pt testing ((b)(6) 2016).Although it is installed, my lab currently is not using the lab pro mbt software to determine acceptability of identifications as this present a significant pt safety risk.We initially contacted beckmann coulter on 08/10/2016 and initiated further discussions on 08/10/2016, 08/15/2016 and 08/18/2016 without any indication from beckman coulter as to when the issue will be resolved.

• Brand Name: LAB PRO MBT
• Type of Device: MICROSCAN WALKAWAY MIDDLEWARE
• Manufacturer (Section D): BECKMAN COULTER, INC.; brea CA 92821
• MDR Report Key: 5903584
• MDR Text Key: 53050934
• Report Number: MW5064331
• Device Sequence Number: 1
• Product Code: LRG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention