MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD MAX¿ SYSTEM; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM

Catalog Number 441916

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

The bd max system is intended for in vitro diagnostic (ivd) use in performing fda cleared or approved nucleic acid testing in clinical laboratories.The bd max system is capable of automated extraction and purification of nucleic acids from multiple specimen types, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based pcr.The complaint of ¿the instrument is allowing them to run while the door is open¿ was investigated by the field service engineer.The field service engineer dispatched to the site found that the door was locked and would not open during the runs.The fse adjusted the door magnet as a precautionary measure, which allows the customer to operate the instrument under normal conditions without further incident.The quality investigation is still underway, and a supplemental report will be filed at the conclusion of this investigation.Device not returned to the manufacturer.

Event Description

Customer reported that the bd max would run while the door was open.No injuries reported.

Manufacturer Narrative

Bd quality has completed the investigation for the bd max¿ system running while the door is open and was unable to confirm the customer complaint.The door on the bd max¿ system automatically locks during sample preparation to prevent the user from accessing the inside of the instrument.The instrument does allow the user to open the door during pcr when the robot is not in motion to set up additional runs.A field service engineer (fse) was dispatched to the site to troubleshoot this customer complaint.The fse was unable to reproduce the complaint.No materials were returned as a result of the complaint as no replacement materials were required.No trends or new hazards have been identified for this failure; therefore, no further action will be taken at this time.Quality will continue to monitor.

• Brand Name: BD MAX¿ SYSTEM
• Type of Device: REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer Contact: carol nieto ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 5867448
• MDR Text Key: 51888905
• Report Number: 1119779-2016-00005
• Device Sequence Number: 1
• Product Code: OOI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Catalogue Number: 441916
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other