LAB PRO MBT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-22 for LAB PRO MBT manufactured by Beckman Coulter, Inc..

Event Text Entries

[53050934] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5064331
• MDR Report Key: 5903584
• Date Received: 2016-08-22
• Date of Report: 2016-08-22
• Date of Event: 2016-08-09
• Date Added to Maude: 2016-08-25
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: LAB PRO MBT
• Generic Name: MICROSCAN WALKAWAY MIDDLEWARE
• Product Code: LRG
• Date Received: 2016-08-22
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECKMAN COULTER, INC.
• Manufacturer Address: BREA CA 92821 US 92821

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2016-08-22