BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2172403 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01744
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 10, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    MOTHER REPORTED THAT PATIENT HAD A MOPED ACCIDENT ON (B)(6) 2011, RESULTING IN TRAUMATIC BRAIN INJURY AND A BROKEN LEFT LEG. MOTHER STATED THE INFUSION DEVICE WAS NOT THE REASON FOR THE ACCIDENT. PATIENT'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. THE PATIENT WAS UNCONSCIOUS AT THE TIME OF THE REPORT. ATTEMPTS TO FOLLOW UP WITH THE MOTHER WERE UNSUCCESSFUL. NO FURTHER INFORMATION WAS AVAILABLE. THE INFUSION DEVICE WAS RETURNED FOR EVALUATION. THE DELIVERY ACCURACY OF THE INFUSION DEVICE WAS TESTED AND MEETS SPECIFICATIONS. THE SOFT COMPONENT OF THE UP BUTTON WAS SLIGHTLY USED UP. TRACES OF CORROSION WERE FOUND UNDERNEATH THE SOFT COMPONENT, AND THIS RESULTED IN A DEFECTIVE DOWN BUTTON WHICH WAS DETECTED DURING THE INVESTIGATION. IN REGULAR USE,THE INFUSION DEVICE IS EXPOSED TO CHEMICAL AND MECHANICAL EFFECTS, AND THE MATERIAL OF THE SOFT COMPONENTS DOES NOT RESIST THESE STRESS FACTORS SUFFICIENTLY. THE MOPED ACCIDENT WAS NOT RELATED TO THE SOFT COMPONENTS, AS THE INFUSION DEVICE HOUSING WAS IN TACT AND HAD NO CRACKS OR DENTS. THE ADAPTER AND ONE USED CARTRIDGE SYSTEM WERE TESTED AND MET SPECIFICATIONS.

    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 16 YR INSULIN| INSULIN INFUSION SET