PLAVIX TEST

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-02 for PLAVIX TEST manufactured by Accumetrics.

Event Text Entries

[1690849] Our lab (b)(6) is using the plavix test made by accumetrics. Several of the techs and i have noticed when taking the tests cartridges out of the machine, blood has been leaking out of vent holes. This is supposed to be a closed system. We do use (b)(6) precautions wearing gloves and (b)(6). Blood is leaking inside the machine. We called the company and asked how we could clean machine. We were told to use a cleaning device. The cleaning device appears only to be (b)(6) tape which does not thoroughly clean blood off the inside instrument. The system is not able to be cleaned with a proper disinfect that would kill infectious diseases. I have concerns that this system is exposing me, and the other techs to hiv or other diseases from blood leaking out of these devices. I had thought that this was a concern at our hospital only, however, when i went to a conference, every tech i talked to said, the blood has leaked into their machine as well. They could not clean it either. This seems to be a health hazard. We would appreciate it if you could look into this matter. I wish to remain anonymous because i have concerns that my job might be at stake to make a fuss of this at work.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5018005
MDR Report Key1892877
Date Received2010-11-02
Date Added to Maude2010-11-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePLAVIX TEST
Generic NameNONE
Product CodeJOZ
Date Received2010-11-02
Device Sequence No1
Device Event Key0
ManufacturerACCUMETRICS


Patients

Patient NumberTreatmentOutcomeDate
10 2010-11-02

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