BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2070234 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01076
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HER INFUSION DEVICE BROKE ON (B)(6) 2011. PT STATED THE PISTON ROD STOPPED WORKING. PT REPORTED SHE ATTEMPTED TO CHANGE HER INSULIN CARTRIDGE ON (B)(6) 2011 AND ATTEMPTED TO RETURN THE PISTON ROD BUT IT WOULD NOT RETURN. PT STATED THE PISTON ROD WAS SPINNING VERY SLOW AND MAKING A DULL HUMMING NOISE. PT REPORTED THE PISTON ROD NEVER RETURNED AND THEN DISPLAYED AN E10 (CARTRIDGE ERROR) MESSAGE. PT STATED SHE ATTEMPTED TO CHANGE THE BATTERY BUT THE SAME THING OCCURRED. HAD PT TRY A NEW BATTERY. ADVISED TO CHANGE THE BATTERY COVER. ON CALL BACK PT REPORTED SHE TRIED A NEW BATTERY AND NEW BATTERY COVER AND THE SAME THING OCCURRED. PT STATED THE PISTON ROD WOULD NOT MOVE AT ALL THIS TIME AND CONTINUED TO MAKE A LOW HUMMING NOISE AND THEN DISPLAYED AN E10 (CARTRIDGE ERROR) MESSAGE. ADVISED PT TO SWITCH TO HER BACKUP INFUSION DEVICE. PT REPORTED HER BACKUP INFUSION DEVICE WAS DESTROYED IN A HOUSE FIRE AND SHE IS CURRENTLY ON INSULIN INJECTIONS. PT STATED AFTER HER INFUSION DEVICE STOPPED WORKING ON (B)(6) 2011, SHE BECAME VERY UPSET WHICH CAUSED HER BLOOD GLUCOSE TO BECOME ELEVATED. PT REPORTED SHE DIDN¿T HAVE ANY WAY TO INJECT INSULIN AS A BACK UP METHOD. PT STATED HER HUSBAND TOOK HER TO THE HOSPITAL BECAUSE OF HER BLOOD GLUCOSE AND WHEN SHE ARRIVED AT THE HOSPITAL HER BLOOD GLUCOSE WAS AROUND 500 MG/DL. PT'S TARGET BLOOD GLUCOSE RANGE IS 200-300 MG/DL. PT REPORTED SHE WAS ADMITTED TO THE HOSPITAL AND GIVEN AN IV OF INSULIN AND LIQUIDS. PT STATED SHE WAS DISCHARGED ON (B)(6) 2011. PT REPORTED SHE WAS INSTRUCTED BY THE DOCTOR TO GIVE INJECTIONS UNTIL SHE IS CONNECTED TO THE INFUSION DEVICE AGAIN. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    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 20 YR Hospitalization| O| R INSULIN (DATE OF TX: (B)(6))| INSULIN INFUSION SET (DATE OF TX (B)(6))