BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1913987 · Received November 19, 2010

    Report

    Report Number
    2183996-2010-02412
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 4, 2010
    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
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT EXPERIENCED ELEVATED BLOOD GLUCOSE NEAR 500MG/DL BECAUSE OF "WRONG OPERATION OF THE PUMP." PT BELIEVED THE PROBLEM WAS BECAUSE THE PISTON ROD COULD NOT EXTEND ITSELF AND DID NOT WORK DURING BASAL DELIVERY. NO ERRORS OR ALARMS WERE RECEIVED. PT SWITCHED TO BACKUP INFUSION DEVICE AND BLOOD GLUCOSE RETURNED TO NORMAL RANGE. TARGET BLOOD GLUCOSE IS 120MG/DL. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OF SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFO WAS PROVIDED.

    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 INSULIN| INSULIN INFUSION SET