BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 AST GN24

    MDR report key: 1902938 · Received November 12, 2010

    Report

    Report Number
    MW5018225
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    September 21, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BIOMERIEUX
    Product Code
    LTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK 2 AST GN24 NONE LTT BIOMERIEUX AST GN24 NA

    Patients

    Seq Age Sex Outcome Treatment
    1