BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1833128 · Received September 9, 2010

    Report

    Report Number
    2183996-2010-01861
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 19, 2010
    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
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, NURSE REPORTED PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 FOR HYPOGLYCEMIA. NURSING REQUESTED ASSISTANCE ON HOW TO VIEW THE INFORMATION REGARDING HOW MUCH INSULIN THE PATIENT HAS RECEIVED WITHIN THE PAST 24 HOURS. ADVISED NURSE, SHE COULD GO INTO THE INFORMATION PAGE ON THE INFUSION DEVICE TO LOOK FOR BOLUS HISTORY. NURSE STATED PATIENT WAS HAVING LOW BLOOD GLUCOSE SYMPTOMS AND HIS FRIEND DROVE HIM TO THE HOSPITAL. NURSE REPORTED THE PATIENT IS CURRENTLY HOMELESS. ADVISED NURSE TO HAVE PATIENT CALL TO PROVIDE DETAILS REGARDING THE INCIDENT. ON CALL BACK PATIENT AND NURSE REQUESTED ASSISTANCE ADJUSTING PATIENT'S BASAL RATES. ASSISTED THEM WITH ADJUSTING BASAL RATES SUCCESSFULLY. PATIENT REPORTED HE WAS ADMITTED ON (B)(6) 2010 BECAUSE HIS BLOOD GLUCOSE READINGS DROPPED. PATIENT STATED HE IS CURRENTLY HOMELESS AND HASN'T BEEN ABLE TO EAT THE WAY HE SHOULD. PATIENT REPORTED HE WAS ALMOST AT THE POINT OF PASSING OUT BUT WAS STILL AWARE OF HIS SURROUNDINGS. PATIENT STATED HE STARTED TO WALK ACROSS THE STREET TO A CHURCH AND WHEN HE STOOD UP TO WALK ACROSS THE STREET, HE FELL DOWN AND HIT HIS HEAD ON THE SIDE WALK. PATIENT REPORTED THE PARAMEDICS WERE CALLED AND THEY BROUGHT HIM TO THE HOSPITAL. PATIENT STATED WHEN THE PARAMEDICS SHOWED UP, HIS BLOOD GLUCOSE READING WAS 37 MG/DL, THEY GAVE HIM 1 TUBE OF GLUCOSE GEL AND THEN HIS READING WAS UP TO 44 MG/DL. PATIENT REPORTED THEY GAVE HIM ANOTHER TUBE OF GEL AND WHEN HE ARRIVED AT THE HOSPITAL, HIS READING WAS 59 MG/DL. PATIENT STATED AT THE HOSPITAL THEY GAVE HIM SOME FOOD TO EAT AND HOOKED HIM UP TO A DEXTROSE IV DRIP. PATIENT'S TARGET BLOOD GLUCOSE RANGE IS 90-140 MG/DL. PATIENT REPORTED HE WAS NOT SURE IF THEY GAVE HIM ANYTHING ELSE. PATIENT STATED HE FEELS THE INFUSION DEVICE IS WORKING CORRECTLY. PATIENT REPORTED THE HOSPITAL STAFF FELT HIS BASAL RATES WERE TOO HIGH FOR HIS CURRENT NEEDS. PATIENT'S INFUSION DEVICE TIME WAS OFF BY ONE HOUR. ASSISTED PATIENT WITH CORRECTING THE TIME. PATIENT REPORTED THERE HAS BEEN A LOT OF STRESS IN HIS LIFE RECENTLY. SENDING USER'S GUIDE; 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 42 YR Hospitalization| O| R INSULIN| INSULIN INFUSION SET