BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2202459 · Received August 5, 2011

    Report

    Report Number
    2183996-2011-02156
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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

    PT REPORTED THAT THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW AND THIS RESULTED IN DIABETIC KETOACIDOSIS 3 WEEKS AGO. PT WAS REFERRED TO AN EMERGENCY DR BY HER GENERAL PRACTITIONER AND WAS TRANSPORTED TO THE HOSP BY AMBULANCE. PT WAS UNCONSCIOUS FOR A SHORT TIME AND ALSO RECEIVED A CARDIAC PACEMAKER. PT HAS BEEN HOSPITALIZED SINCE (B)(6) 2011 FOR A DIABETES RE-ADJUSTMENT. HER INFUSION PORT SWELLED ON (B)(6) 2011, BUT THE INFUSION DEVICE DID NOT DISPLAY AN E4 OCCLUSION. BLOOD GLUCOSE WAS 290 MG/DL AT 12:10 PM AND 321 MG/DL AT 2:30 PM ON (B)(6) 2011. PT DELIVERED 2 I.E. VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS 375 MG/DL AT 4 PM, AND PT DELIVERED 4 I.E. VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS 480 MG/DL AT 6 PM, AND PT DELIVERED 6 I.E. VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS 589 MG/DL AT 8 PM. PT WAS POSITIVE FOR KETONES. SHE STOPPED USING THE INFUSION DEVICE AND NOTICED THE CARTRIDGE COMPARTMENT WAS WET. DIET COUNSELOR AND DIABETES SPECIALIST ALSO BELIEVE THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW. PT DID NOT HAVE AN INFECTION. NORMAL BLOOD GLUCOSE IS 150 MG/DL DURING THE DAYTIME AND 200 MG/DL AT NIGHT. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. CORRECT TYPE OF BATTERY WAS USED IN THE INFUSION DEVICE, AND THE BATTERY SETTING WAS PROGRAMMED CORRECTLY. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO ADD'L INFO WAS PROVIDED.

    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 82 YR Hospitalization| R INSULIN INFUSION SET| INSULIN| (DATE OF TX APPROX: (B)(6) 2011)