BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2070420 · Received April 19, 2011

    Report

    Report Number
    2183996-2011-01107
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED THAT 3 DAYS AGO ALL BUTTONS ON THE INFUSION DEVICE WERE UNRESPONSIVE AND HE SWITCHED TO HIS BACKUP INFUSION DEVICE. TO TROUBLESHOOT, THE PT INSERTED A NEW BATTERY AND THE BUTTONS FUNCTIONED PROPERLY. THE PT STATED, HE WOULD SWITCH BACK TO THE PRIMARY DEVICE. THE PT CALLED BACK ON (B)(6) 2011 AND STATED, THE BUTTONS WERE UNRESPONSIVE. THE KEYLOCK WAS NOT ACTIVATED AND THE INFUSION DEVICE WAS IN THE STOP MODE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR INSULIN INFUSION SET| INSULIN