BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2002794 · Received February 8, 2011

    Report

    Report Number
    2183996-2011-00108
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 17, 2011
    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
    GM
    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

    THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF UP TO 240 MG/DL ON THE THIRD DAY OF USING HER INSULIN CARTRIDGE. SHE STATED SHE USES PARTIALLY FILLED INSULIN CARTRIDGES. SHE BOLUSED THROUGH THE INFUSION DEVICE AND WAS UNABLE TO LOWER HER BLOOD GLUCOSE. SHE CHANGED THE INSULIN CARTRIDGE AND ACCESSORIES AND HER BLOOD GLUCOSE DECREASED. SHE STATED THAT SOMETIMES HER BLOOD GLUCOSE BECOMES TOO LOW. ON (B)(6) 2011, HER BLOOD GLUCOSE RANGED FROM 172-246 MG/DL BETWEEN 7:15-10:24 AM. SHE CHANGED HER ACCESSORIES AT 8:30 AM AND HER BLOOD GLUCOSE BEGAN TO DECREASE AT 11:05 AM (218 MG/DL). AT 2:35 PM, HER BLOOD GLUCOSE MEASURED 108 MG/DL AND LATER DECREASED TO 62 MG/DL. ON (B)(6) 2011, HER BLOOD GLUCOSE MEASURED 208 MG/DL AT 5:08 AM AND DID NOT INCREASE ABOVE 150 MG/DL THE REST OF THE DAY. THE PT'S NORMAL BLOOD GLUCOSE RANGE WAS NOT PROVIDED. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR INSULIN INFUSION SET| INSULIN