BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2132589 · Received June 10, 2011

    Report

    Report Number
    2183996-2011-01663
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 19, 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
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED SHE WAS HAVING ISSUES WITH THE PISTON ROD RETRACTING ON THE INFUSION DEVICE. PT STATED SHE ATTEMPTED TO COMPLETE THE CHANGE THE CARTRIDGE PROCESS AND RECEIVED AN E10 (CARTRIDGE ERROR) MESSAGE. PT REPORTED THERE WERE 42.0 UNITS OF INSULIN LEFT IN THE INSULIN CARTRIDGE. PT STATED SHE INSERTED A NEW BATTERY AND ATTEMPTED TO COMPLETE THE CHANGE THE CARTRIDGE PROCESS AGAIN. PT REPORTED SHE WAS ABLE TO RETRACT AND ADJUST THE PISTON ROD SUCCESSFULLY. PT STATED SHE WAS ABLE TO PRIME THE INFUSION SET, RECONNECT TO HER INFUSION SITE, AND PLACE THE INFUSION DEVICE IN THE RUN MODE. PT REPORTED HAVING LOW BLOOD GLUCOSE ISSUES OVER THE PAST FEW WEEKS. PT STATED SHE HAS HAD LOW BLOOD GLUCOSE CONCERNS SINCE (B)(6) 2011. PT REPORTED HER BLOOD GLUCOSE READINGS WERE AS LOW AS 55 MG/DL. PT STATED SHE ATTEMPTED TO DRINK ORANGE JUICE TO BRING HER BLOOD GLUCOSE BACK UP. PT'S TARGET BLOOD GLUCOSE RANGE IS 170-200 MG/DL. PT REPORTED THAT ONE LOW BLOOD GLUCOSE EPISODE CAUSED HER TO GO TO THE HOSPITAL. PT STATED ONE DAY SHE LEFT FOR LUNCH AND STARTED FEELING BAD IMMEDIATELY. PT REPORTED SHE GOT SO CONFUSED SHE WAS UNABLE TO FIND HER WAY BACK TO WORK. PT STATED SHE HAD TO HAVE HER HUSBAND BRING HER SOME ORANGE JUICE AND THEN HE TOOK HER TO THE EMERGENCY ROOM. PT REPORTED SHE WAS DRINKING THE JUICE ON THE WAY AND HER BLOOD GLUCOSE LEVEL WAS 168 MG/DL WHEN SHE ARRIVED AT THE HOSPITAL. PT STATED SHE DIDN'T RECEIVE ANY SPECIAL TREATMENT BUT THEY DID RUN HEART TESTS. PT REPORTED SHE WAS RELEASED LATER THAT NIGHT. PT STATED HER BLOOD GLUCOSE LEVEL WAS 66 MG/DL DURING THE CALL AND SHE FELT FINE AND IS ABOUT TO EAT. ON FOLLOW UP CALL ON (B)(6) 2011, PT REPORTED HER BLOOD GLUCOSE LEVEL HAS RETURNED TO NORMAL. 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 43 YR Hospitalization| R INSULIN| INSULIN INFUSION SET