BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2253026 · Received August 31, 2011

    Report

    Report Number
    2183996-2011-02361
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 26, 2011
    Report Date
    August 26, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-4115-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011 PT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE STOPPED RESPONDING THIS MORNING. PT STATED THE BUTTONS WERE WORKING FINE YESTERDAY, BUT WHEN SHE ATTEMPTED TO PROGRAM A BOLUS THIS MORNING, THE DOWN BUTTON WOULD NOT RESPOND. PT REPORTED SHE PROGRAMMED TOO MANY UNITS THIS MORNING AND COULD NOT DECREASE THE AMOUNT. PT STATED SHE WAS ABLE TO LET IT TIME OUT, SO IT DID NOT DELIVER THE BOLUS. PT STATED THE BUTTONS POP BACK UP WHEN PRESSED. PT REPORTED SHE WAS AWARE OF THE RECALL CONCERN. OFFERED TO ASSIST PT WITH SWITCHING TO HER BACKUP INFUSION DEVICE; PT DECLINED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    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 49 YR INSULIN| INSULIN INFUSION SET