BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1981882 · Received January 14, 2011

    Report

    Report Number
    2183996-2010-02779
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 21, 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 REPORTED DURING THE PAST MONTH, EVERY TIME THE INSULIN CARTRIDGE WAS ABOUT AT 100 UNITS OF INSULIN, HIS BLOOD GLUCOSE VALUE WOULD INCREASE. PT STATED DURING THE LATEST DAYS, HIS BLOOD GLUCOSE REACHED 300 MG/DL. PT'S NORMAL BLOOD GLUCOSE VALUE IS ABOUT 140 MG/DL. PT STATED HE HAS THE FEELING THE INFUSION DEVICE DOESN'T DELIVER THE RIGHT AMOUNT OF INSULIN WHEN IT DELIVERS THE BASAL RATE. PT REPORTED WHEN HE GAVE A CORRECTIVE BOLUS, EVEN OF 8.0 UNITS OF INSULIN, NOTHING HAPPENED. PT STATED THE BLOOD GLUCOSE VALUED BEGAN DECREASING AFTER SEVERAL CORRECTIVE BOLUSES. PT REPORTED THE PLASTIC COVER NEAR THE UP AND DOWN BUTTONS IS TORN, AND THE PLASTIC ABOVE THE DOWN BUTTON IS COMPLETELY BROKEN. PT STATED DURING THE ENTIRE PAST MONTH, THE INFUSION DEVICE HAD SOME DELIVERY MALFUNCTIONS EVEN THOUGH IT SEEMS TO WORK PROPERLY AND NO ALARM CODE APPEARED ON THE DISPLAY. PT REPORTED WHEN HE CONNECTED TO THE BACKUP INFUSION DEVICE, HIS BLOOD GLUCOSE VALUES RETURNED TO NORMAL. NO FURTHER INFO IS AVAILABLE. 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 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 INSULIN| INSULIN INFUSION SET