BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2070359 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01074
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 21, 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
    UK
    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 SHE DOES NOT BELIEVE THE INFUSION DEVICE IS DELIVERING INSULIN CORRECTLY. ON (B)(6) 2011, PT WOKE IN THE MIDDLE OF THE NIGHT AND BLOOD GLUCOSE WAS 20 MMOL/L (360 MG/DL). SHE DELIVERED A BOLUS OF 3 UNITS AND WENT BACK TO SLEEP. AT 7:00 A.M., HER BLOOD GLUCOSE WAS STILL IN THE RANGE OF 20 MMOL/L (360 MG/DL) AND SHE DELIVERED A BOLUS OF 1 UNIT. AN E4 OCCLUSION OCCURRED ON THE INFUSION DEVICE, AND SHE CHANGED THE INFUSION SET AT 7:15 A.M. PT DELIVERED AN ADD'L 4.5 UNITS AT 7:30 A.M., 2.5 UNITS AT 8:00 A.M., 5.5 UNITS AT 11:00 A.M., 7 UNITS AT 12:45 P.M., AND 3.5 UNITS AT 1:30 P.M. BLOOD GLUCOSE EVENTUALLY DECREASED LATER THAT DAY. PT REPORTED, THE INFUSION DEVICE DID NOT GIVE AN E4 OCCLUSION ALARM WHEN IT SHOULD HAVE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADD'L DETAILS WERE NOT 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