BD MAX? SYSTEM 441916

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2016-08-10 for BD MAX? SYSTEM 441916 manufactured by Becton, Dickinson & Co..

Event Text Entries

[51888905] 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.
Patient Sequence No: 1, Text Type: N, H10


[51888906] Customer reported that the bd max would run while the door was open. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5


[53946499] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1119779-2016-00005
MDR Report Key5867448
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2016-08-10
Date of Report2016-09-02
Date of Event2016-07-07
Date Mfgr Received2016-07-07
Date Added to Maude2016-08-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBDX CAROL NIETO
Manufacturer Street7 LOVETON CIRCLE
Manufacturer CitySPARKS MD 21152
Manufacturer CountryUS
Manufacturer Postal21152
Manufacturer Phone4103164000
Manufacturer G1BECTON, DICKINSON & CO.
Manufacturer Street7 LOVETON CIRCLE
Manufacturer CitySPARKS MD 21152
Manufacturer CountryUS
Manufacturer Postal Code21152
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD MAX? SYSTEM
Generic NameREAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
Product CodeOOI
Date Received2016-08-10
Catalog Number441916
OperatorMEDICAL TECHNOLOGIST
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON & CO.
Manufacturer Address7 LOVETON CIRCLE SPARKS MD 21152 US 21152


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-08-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.