BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK SPIRIT

    MDR report key: 1811534 · Received August 17, 2010

    Report

    Report Number
    2183996-2010-01629
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 25, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1415-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE WAS NOT FUNCTIONING PROPERLY. THIS WAS NOTICED EARLIER IN THE EVENING WHEN ATTEMPTING TO DELIVER A BOLUS. PATIENT STARTED THIS INFUSION DEVICE A COUPLE OF YEARS AGO AND DELIVERS 5-6 BOLUS PER DAY. THE DOWN BUTTON IS RAISED AND DOES NOT PRODUCE BEEPS OR VIBRATIONS WHEN IT IS PRESSED. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO LIQUIDS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR INSULIN INFUSION SET| INSULIN