BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2190594 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02111
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    February 19, 2011
    Report Date
    July 19, 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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HE HAS HAD AN ISSUE WITH HIS INFUSION DEVICE FOR THE PAST 4-5 MONTHS. PT STATED THERE IS A BLACK BLOTCH IN THE UPPER LEFT HAND CORNER OF HIS SCREEN. PT REPORTED IT SOMETIMES GETS IN THE WAY OF THE RESULTS FIELD WITH THE BASAL RATES AND BOLUSES. PT STATED HE HAS USED DIFFERENT TYPES OF BATTERIES AND THERE IS STILL AN ISSUE WITH THE BLACK SPLOTCH. ADVISED PT ON CORRECT BATTERY TYPE TO USE. HAD PT TO CORRECT THE SETTING ON THE INFUSION DEVICE TO MATCH THE TYPE OF BATTERY HE IS USING. PT REPORTED THE BATTERY LIFE IS ALSO LOW SOMETIMES. ADVISED PT THAT COULD BE DUE TO NOT HAVING THE CORRECT SETTING ON THE INFUSION DEVICE. 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 SUSPECT PRODUCT 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 32 YR INSULIN INFUSION SET| INSULIN