BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1983804 · Received January 20, 2011

    Report

    Report Number
    2183996-2011-00033
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 11, 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. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE FOR 2 WEEKS. ON (B)(6) 2011, HER BLOOD GLUCOSE MEASURED 212 MG/DL AT 10:30PM. ON (B)(6) 2011, HER BLOOD GLUCOSE MEASURED 350 MG/DL AT 2:00AM AND SHE VOMITED AND FELT VERY SICK. SHE BOLUSED 3 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. AT 2:30AM, SHE VOMITED AGAIN. AT 3:00AM, HER BLOOD GLUCOSE MEASURED 280 MG/DL. AT 4:15AM, IT MEASURED 240 MG/DL AND SHE BOLUSED 0.5 UNITS INSULIN. AT 8:30AM, HER BLOOD GLUCOSE MEASURED 180 MG/DL AND SHE ATE AND BOLUSED 6 UNITS OF INSULIN. AT 10:30AM, HER BLOOD GLUCOSE MEASURED 300 MG/DL AND SHE BOLUSED 3-4 UNITS OF INSULIN. AT 12:00PM, HER BLOOD GLUCOSE MEASURED 300 MG/DL AND SHE CHANGED THE INSULIN CARTRIDGE, INFUSION SITE, AND TUBING AND BOLUSED 5 UNITS OF INSULIN. AT 1:00PM, HER BLOOD GLUCOSE MEASURED 280 MG/DL AND SHE BOLUSED 2-3 UNITS OF INSULIN. AT 1:30PM, HER BLOOD GLUCOSE MEASURED 290 MG/DL, AT 3:00PM MEASURED 150 MG/DL, AND AT 4:00PM MEASURED 90 MG/DL. SHE ATE AND AT 5:00PM, HER BLOOD GLUCOSE MEASURED 187 MG/DL AND SHE BOLUSED 1 UNIT OF INSULIN. AT 6:00PM, HER BLOOD GLUCOSE MEASURED 220 MG/DL, AT 7:00PM MEASURED 150 MG/DL, AT 7:45PM MEASURED 50 MG/DL AND SHE ATE. THE PATIENT BELIEVES THE INFUSION DEVICE DELIVERS TOO LITTLE INSULIN. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    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 31 YR INSULIN| INSULIN INFUSION SET