BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2031031 · Received March 16, 2011

    Report

    Report Number
    2183996-2011-00528
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ROCHE INSULIN SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, MOTHER REPORTED PT WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. PT WAS VOMITING ALL NIGHT AND WAS TAKEN TO THE EMERGENCY ROOM, AND HIS BLOOD GLUCOSE WAS APPROX 580 MG/DL. TARGET BLOOD GLUCOSE IS 100-200 MG/DL. THE INFUSION DEVICE WAS IN THE STOP MODE AT THE TIME OF THE REPORT. MOTHER ASKED TO BE CONTACTED AT A LATER TIME TO COMPLETE TROUBLESHOOTING. FOLLOW-UP WAS COMPLETED WITH MOTHER ON (B)(6) 2011. PT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND HIS PH LEVEL WAS 0.3, WHICH WAS CONSIDERED LIFE-THREATENING. PT WAS ADMITTED TO CRITICAL CARE UNIT BUT WAS AT HOME AND FEELING WELL AT THE TIME OF FOLLOW-UP. PT WENT ON A 4-WHEELER RIDE ON (B)(6) 2011 AND DISCONNECTED FROM THE INFUSION DEVICE. MOTHER DID NOT KNOW HOW LONG HE WAS DISCONNECTED FROM THE INFUSION DEVICE. PT FELT LIKE HE HAD ACID IN HIS STOMACH ON (B)(6) 2011 AND TOOK MEDICINE. HE VOMITED AND FELT BETTER. BLOOD GLUCOSE WAS BETWEEN 300-599 MG/DL. ON THE MORNING OF (B)(6) 2011, PT WAS TAKEN TO THE HOSPITAL BY HIS MOTHER. HE RECEIVED TWO BLOOD GLUCOSE READINGS OF "HI" AND ONE READING OF 580 MG/DL. MOTHER REPORTED HE WAS CONNECTED TO THE INFUSION DEVICE WHEN SHE TOOK HIM TO THE HOSPITAL. PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011 AND WAS TREATED WITH AN IV INSULIN DRIP WHILE HE WAS THERE . MOTHER BELIEVES PT WAS NOT MANAGING HIS DIABETES PROPERLY PRIOR TO THE INCIDENT, AND NO ALLEGATIONS WERE MADE AGAINST THE INFUSION DEVICE OR RELATED PRODUCTS. NO PRODUCT WAS REQUESTED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R INSULIN INFUSION SET ((B)(6))| INSULIN ((B)(6))