BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2231667 · Received July 22, 2011

    Report

    Report Number
    2183996-2011-02096
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 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

    PT REPORTED, THE INFUSION DEVICE DOES NOT CORRECTLY DISPLAY E1 CARTRIDGE EMPTY ERRORS, AND THIS HAS BEEN ONGOING SINCE PT STARTED TO USE THIS INFUSION DEVICE 1 YR AGO. THE CARTRIDGE VOLUME WAS 2 UNITS AT 5:00 A.M. ON (B)(6) 2011 AND 0 UNITS AT 7:30 A.M. THE INFUSION DEVICE DID NOT DISPLAY AN E1 CARTRIDGE EMPTY ERROR. NO PHYSIOLOGICAL EFFECTS WERE EXPERIENCED AS PT CHECKS THE INFUSION DEVICE "ALL THE TIME." PT DID NOT START NEW MEDICATION OR HAVE AN INFECTION, AND HER NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. INFUSION DEVICE WAS NOT DROPPED ON THE FLOOR OR EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. CORRECT TYPE OF BATTERY IS USED IN THE INFUSION DEVICE, AND THE BATTERY SETTING IS PROGRAMMED CORRECTLY. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 43 YR INSULIN| INSULIN INFUSION SET