BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2943290 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00012
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INFUSION DEVICE WAS THOROUGHLY CHECKED. THE SOFT RUBBER COMPONENTS OF THE PUMP HOUSING ARE WORN DOWN HEAVILY. THEREFORE, MOISTURE MAY ENTER THE INSULIN PUMP AND DESTROY THE PUMP ELECTRONICS. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PT REPORTED THE PROTECTIVE RUBBER PEELED OFF THE MENU BUTTON AND ALL BUTTONS STOPPED FUNCTIONING 2 DAYS AGO. THE GROUND-PLATE OF THE INFUSION DEVICE IS VISIBLE. HIS BLOOD GLUCOSE INCREASED TO 210 MG/DL BECAUSE HE WAS UNABLE TO BOLUS, AND HIS TARGET RANGE IS 160-168 MG/DL. THE BUTTONS ARE NOT FLAT AND DO NOT PRODUCE AN AUDIBLE SOUND OR WORK EVEN IF PRESSED HARD. THE INFUSION DEVICE WAS NOT DROPPED ON A HARD SURFACE. PT SWITCHED TO HIS BACKUP INFUSION DEVICE DURING THE CALL. F/U WAS COMPLETED LATER THE SAME DAY. HE HAD REMOVED THE BATTERY WITHOUT PUTTING THE INFUSION DEVICE IN STOP, AND AN E8 POWER INTERRUPT ERROR APPEARED WHEN A NEW BATTERY WAS INSERTED. HE WAS UNABLE TO CLEAR THE ERROR MESSAGE DUE TO THE DEFECTIVE BUTTONS. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. HIS BLOOD GLUCOSE RETURNED TO NORMAL WHEN HE WAS ABLE TO BOLUS USING THE BACKUP INFUSION DEVICE, AND NO TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28706 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES