BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1890029 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02210
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 13, 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
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED PARAMEDICS WERE CALLED ON (B)(6) 2010. PT WAS INCOHERENT AND UNRESPONSIVE IN A PARKING LOT. A PASSERBY CALLED AN AMBULANCE FOR PT. PT DID NOT LOSE CONSCIOUSNESS. BLOOD GLUCOSE WAS 37 MG/DL, AND PT WAS ADMINISTERED "SUGAR DRIP" IN THE AMBULANCE. PT WAS NOT TAKEN TO THE HOSPITAL, AT HER REQUEST. BLOOD GLUCOSE RETURNED TO NORMAL LEVELS. INSULIN CARTRIDGE WAS IN USE FOR 1-2 WEEKS. TIME, DATE AND BASAL RATES WERE PROGRAMMED CORRECTLY. INFUSION DEVICE BUTTONS WERE FUNCTIONING AS INTENDED. PT DID NOT COMPLETE PRIME WITH INFUSION SET CONNECTED TO HER BODY. PT DID NOT CONSUME ALCOHOL AND THERE WERE NO LIFESTYLE CHANGES. INFUSION DEVICE WAS NOT DROPPED, CRACKED OR EXPOSED TO LIQUID. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. SEVERAL ATTEMPTS WERE MADE TO REACH PT FOR ADDITIONAL INFORMATION AND THESE WERE UNSUCCESSFUL.

    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 55 YR Required Intervention INSULIN INFUSION SET| INSULIN