BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1810136 · Received August 17, 2010

    Report

    Report Number
    2183996-2010-01632
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 21, 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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, HOSPITAL NURSE REPORTED PATIENT WAS ADMITTED FOR HYPERGLYCEMIA. NURSE REQUESTED ASSISTANCE ADJUSTING BASAL RATES ON INFUSION DEVICE AND THIS WAS PROVIDED. FOLLOW-UP WAS COMPLETED WITH PATIENT. PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2010 FOR KETOACIDOSIS AND AN INFECTION OF THE ESOPHAGUS. PATIENT WAS IN THE INTENSIVE CARE UNIT OF THE HOSPITAL FOR 5 DAYS. PATIENT WAS TRANSPORTED TO HOSPITAL BY AMBULANCE. BLOOD GLUCOSE WAS 550 MG/DL WHEN PATIENT ARRIVED AT HOSPITAL. TARGET BLOOD GLUCOSE IS 140-200 MG/DL. PATIENT DID NOT RECEIVE ANY ERRORS ON INFUSION DEVICE. PATIENT CHANGED HIS INFUSION SET ON (B)(6) 2010 AND THEN RAN OUT OF TEST STRIPS FOR HIS GLUCOMETER. BLOOD GLUCOSE WAS NORMAL PRIOR TO CHANGING INFUSION SITE. PATIENT WAS UNABLE TO CHECK HIS BLOOD GLUCOSE AND DELIVERED BOLUSED BY "GUESSING." PATIENT THEN EXPERIENCED VOMITING FOR 24 HOURS. PATIENT DID NOT WISH TO PROVIDE FURTHER DETAILS. PATIENT WAS USING INFUSION DEVICE AT THE TIME OF FOLLOW-UP. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. INFUSION SETS WERE REPLACED.

    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 52 YR Hospitalization| R INSULIN| INSULIN INFUSION SET