BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1910261 · Received November 22, 2010

    Report

    Report Number
    2183996-2010-02473
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 15, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED EXTREMELY HIGH BLOOD GLUCOSE ON THE MORNING OF (B)(6) 2010. PT WAS ADMITTED TO THE HOSPITAL WITH DIABETIC KETOACIDOSIS. BLOOD GLUCOSE WAS SLIGHTLY ELEVATED ON (B)(6) 2010. PT DELIVERED A CORRECTION BOLUS AND WENT TO BED. PT WOKE AT 7:30 AM ON (B)(6) 2010 AND WAS THROWING UP. BLOOD GLUCOSE WAS "HI" MG/DL. PT DELIVERED A CORRECTION BOLUS, BUT BLOOD GLUCOSE DID NOT DECREASE. AT 11:30 PM., PT WAS STILL THROWING UP AND COULD NOT CATCH HIS BREATH. PT WENT TO THE HOSPITAL AND BLOOD GLUCOSE WAS 1250 MG/DL. PT WAS TREATED WITH AN INSULIN IV AND WAS IN INTENSIVE CARE UNIT FOR 2.5 DAYS. PT WAS TOLD HE MAY HAVE HAD A HEART ATTACK. PT WAS DISCHARGED ON (B)(6) 2010, AND BLOOD GLUCOSE RETURNED TO TARGET RANGE OF 100-150 MG/DL WHILE ON BACKUP INFUSION DEVICE. INFUSION SET, INSULIN CARTRIDGE, BATTERY COVER, AND ADAPTER ARE USED PER SPEC. THERE WERE NO AIR BUBBLES OR BLOOD IN THE INFUSION TUBING OR INSULIN CARTRIDGE AT TIME OF EVENT. THERE WERE NO LEAKS OF INSULIN IN THE SYSTEM. PT HEARD INFUSION DEVICE DELIVER INSULIN AND COULD SEE THE CARTRIDGE GETTING LOWER. THERE WERE NO CHANGES TO DIET, MEDICATION, OR LIFESTYLE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL.

    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 57 YR Hospitalization| R INSULIN INFUSION SET| INSULIN