BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSITITRE YEASTONE SUSCEPTIBILITY PLATE

    MDR report key: 2031705 · Received March 22, 2011

    Report

    Report Number
    8021914-2011-00001
    Event Type
    Death
    Date Received
    March 22, 2011
    Report Date
    March 17, 2011
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS, LTD.
    Product Code
    LQM
    PMA / PMN Number
    K001810/S
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO DISCONTINUANCE OF A SUSCEPTIBILITY PANEL, MAILINGS ARE SENT TO ALL CUSTOMERS USING THE PANEL TO INFORM THEM OF THE INTENT TO REPLACE THE PANEL WITH AN UPDATED PANEL. THE MAILING WENT OUT IN (B)(6), 2010 TO ALL USER FACILITIES. INCLUDED WITH THE MAILING IS A LAYOUT OF THE UPDATED PANEL FOR THE LABORATORIES TO USE IN PREPARATION OF REPORTING FORMATS THEY NEED PRIOR TO THE IMPLEMENTATION OF THE NEW PRODUCT. ALTHOUGH THE INSTITUTION WAS VERIFIED TO BE INCLUDED IN THE NOTIFICATION LIST OF THE INTENT TO DISCONTINUE (B)(4) AND REPLACE WITH (B)(4), THE INSTITUTION STATED THAT THE NOTIFICATION WAS NOT RECEIVED BY ANY OF THE LABORATORY PERSONNEL. ALSO INCLUDED WITH THE PRODUCT LABEL ARE DIRECTIONS TO THE TREK WEBSITE WHERE PLATE LAYOUT AND PRODUCT TECHNICAL INFORMATION CAN BE FOUND.

    Description of Event or Problem · 1

    THE INSTITUTION REPORTED THAT ERRONEOUS SUSCEPTIBILITY RESULTS FOR TWO PATIENTS WERE RELEASED BY THEIR LABORATORY IN (B)(6) 2011, BUT THE ERROR WAS NOT IMMEDIATELY DISCOVERED. THESE EVENTS OCCURRED DUE TO THE LABORATORY USING AN INCORRECT SUSCEPTIBILITY PANEL RECORDING FORMAT. TREK RECEIVED CONFIRMATION ON (B)(6), 2011 THAT THE LABORATORY HAD REPORTED ERRONEOUS RESULTS. RESULTS FOR FLUCONAZOLE WERE REPORTED AS SUSCEPTIBLE DOSE DEPENDENT (SDD) WHEN THEY WERE IN FACT RESISTANT (R). THE INITIAL REPORTED STATED THE FOLLOWING IN A COMMUNICATION DATED (B)(6), 2011 "BOTH PATIENTS WERE IMMUNOCOMPROMISED AND HAD OTHER UNDERLYING DISEASES. THE PATIENT THAT EXPIRED PROBABLY DIED FROM OTHER AILMENTS BEING SHE WAS ONLY ON FLUCONAZOLE FOR ABOUT 5 DAYS. THE SECOND PATIENT DOES NOT SEEM TO HAVE HAD ANY DIRECT ADVERSE EFFECT FROM THE FLUCONAZOLE TREATMENT, HOWEVER, FUTURE FLUCONAZOLE RESISTANCE MAY BE A POSSIBILITY IF THE FUNGAL INFECTION RECURS." THE PANEL FORMAT FOR (B)(4) (A PANEL THAT WAS DISCONTINUED IN 2010) WAS BEING USED FOR MANUALLY RECORDING RESULTS IN PLACE OF THE PANEL FORMAT FOR (B)(4) WHICH WAS THE PLATE THAT THE CUSTOMER WAS USING FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSITITRE YEASTONE SUSCEPTIBILITY PLATE NONE LQM TREK DIAGNOSTIC SYSTEMS, LTD. B0382

    Patients

    Seq Age Sex Outcome Treatment
    1 Death