BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2132567 · Received June 10, 2011

    Report

    Report Number
    2183996-2011-01638
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 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
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HE HAS BEEN GETTING ERRATIC BLOOD GLUCOSE READINGS. PT STATED HE HAS BEEN USING THE INFUSION DEVICE FOR 2 WEEKS AND IS NEW TO PUMP THERAPY. PT REPORTED HE HAS HAD ELEVATED BLOOD GLUCOSE READINGS AT LEAST TWICE A DAY FOR THE PAST WEEK. PT STATED HIS BLOOD GLUCOSE READING WAS 254 MG/DL ON (B)(6) 2011 AND 174 MG/DL ON (B)(6) 2011. PT REPORTED HE RECEIVED A REALLY LOW BLOOD GLUCOSE READING TODAY AND THE PARAMEDICS WERE CALLED BY HIS FAMILY. PT STATED HE DOESN'T RECALL ANY SYMPTOMS OR HOW LOW HIS BLOOD GLUCOSE WAS. PT REPORTED HE WASN'T ALERT ENOUGH. PT STATED THE PARAMEDICS GAVE HIM A GLASS OF JUICE AND HE ATE A SANDWICH. PT REPORTED THEY DID NOT TAKE HIM TO THE HOSPITAL. PT'S NORMAL BLOOD GLUCOSE RANGE IS AROUND 100 MG/DL. PT STATED THE INFUSION DEVICE DID NOT DISPLAY ANY ERROR MESSAGES. PT REPORTED HIS BASAL RATES ARE SET CORRECTLY BUT HE INCREASED IT TO 0.1 UNITS OF INSULIN FOR SEVERAL HOURS STARTING 2 DAYS AGO. PT STATED HE DID THIS ON HIS OWN WITHOUT THE DOCTOR'S ADVICE. PT DECLINED TO DO BOLUS AND WASTE INSULIN. PT REPORTED THERE WAS NO LEAKING AT THE INFUSION SITE OR IN THE SYSTEM. PT STATED HE HAS NOT FORGOTTEN ANY MEAL BOLUSES BUT IS UNSURE IF HE IS GIVING HIMSELF THE CORRECT AMOUNTS OF INSULIN BECAUSE HIS BOLUS CALCULATOR IS NOT WORKING AT ALL. ADVISED PT TO SPEAK WITH HIS DOCTOR ABOUT CONCERNS WITH HIS BLOOD GLUCOSE LEVELS. PT REPORTED HE THINKS HIS ERRATIC READINGS ARE DUE TO HIM NOT KNOWING HOW MUCH TO BOLUS SINCE HIS BOLUS CALCULATOR IS NOT SET UP YET. SUBMITTED REQUEST FOR ASSISTANCE TO HAVE TRAINER COME OUT AND ASSIST PT. ON FOLLOW UP ON (B)(6) 2011, CLINICAL TRAINER REPORTED TALKING WITH THE PT'S SISTER AND THEN MEETING WITH THE PT ON (B)(6) 2011. TRAINER STATED THEY REVIEWED PUMP TRAINING AND SET UP A MUTUALLY AGREEABLE PLAN OF CARE. NO PRODUCT RETURN WAS REQUESTED.

    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 60 YR Required Intervention INSULIN| INSULIN INFUSION SET