BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1730959 · Received June 17, 2010

    Report

    Report Number
    2183996-2010-01288
    Event Type
    Injury
    Date Received
    June 17, 2010
    Date of Event
    May 19, 2009
    Report Date
    May 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
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED APPROX A YEAR AGO, HER NEIGHBOR FOUND HER UNRESPONSIVE AND EMERGENCY TECHNICIANS WERE CALLED; WAS ADMITTED TO THE HOSP. PT STATED WHILE AT THE HOSP, THEY WERE UNABLE TO GET A BLOOD GLUCOSE RESULT ON THEIR METERS; THEY WERE JUST READING "HI". PT REPORTED THEY DREW BLOOD AND THE BLOOD GLUCOSE READING THEY OBTAINED WAS 2100 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 140-200 MG/DL. TREATMENT RECEIVED WAS NOT PROVIDED. PT STATED, THE INFUSION DEVICE DID NOT GIVE ANY ALERTS OR ERRORS. PT IS NOT CURRENTLY USING THE INFUSION DEVICE; HAS NOT BEEN USING THE DEVICE FOR 6 MONTHS. PT DECLINED THE OFFER OF A REPLACEMENT DEVICE. PT REPORTED, HER DOCTOR DOES NOT WANT HER TO BE ON AN INSULIN INFUSION DEVICE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE 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 37 YR Hospitalization| O| R INSULIN INFUSION SET| INSULIN