VITEK 2 AST GN24 22229

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-12 for VITEK 2 AST GN24 22229 manufactured by Biomerieux.

Event Text Entries

[20746325] Notified on (b)(6) 2010 by biomerieux that our vitek 2 susceptibility to piperacillin/tazobactam -tzp- for escherichia coli and klebsiella pneumoniae was not accurate. Escherichia coli isolates reported as sensitive may be resistant and klebsiella pneumoniae isolates that are resistant may be susceptible. In response to this, ptz results were immediately withheld for e coli and all resistant results for k pneumo to ptz were backed up with another method. Then, the microbiology lab and pharmacy pulled all of the inpatients treated with ptz for the period from (b)(6) 2010 -date biomerieux changed ptz formulation on the card- to (b)(6) 2010 that grew e. Coli or k pneumoniae. There were 19 pts with 2 being discharged on ptz. All pt results were reviewed, and it was determined that only 1 physician required notification by phone. A memo was then sent to all staff and physicians regarding the withholding of e. Coli and ptz results with a coded comment generated and attached to all e. Coli isolates and reported to the electronic medical record. The memo also included notification that the lab would check ptz resistant k pneumoniae isolates. Any provider that was using ptz prior results to base initializing therapy was notified by memorandum to send a new clinical specimen prior to prescribing. All providers were referred to the infectious diseases team or to call the lab for additional questions. Dose or amount: not applicable. Dates of use: (b)(6) 2009 - (b)(6) 2010. Diagnosis or reason for use: isolate susceptibility testing. Biomerieux vitek 2 ast gn24 card with piperacillin/tazobactam, (b)(6) 2009 through present.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5018225
MDR Report Key1902938
Date Received2010-11-12
Date of Report2010-11-12
Date of Event2010-09-21
Date Added to Maude2010-11-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVITEK 2 AST GN24
Generic NameNONE
Product CodeLTT
Date Received2010-11-12
Model NumberAST GN24
Catalog Number22229
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX
Manufacturer Address100 RODOLPHE ST DURHAM NC 27712 US 27712


Patients

Patient NumberTreatmentOutcomeDate
10 2010-11-12

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