BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2921681 · Received January 11, 2013

    Report

    Report Number
    2183996-2012-02097
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 9, 2013
    Report Date
    December 20, 2012
    Manufacturer
    ROCHE HEALTH SOLUATIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S SISTER REPORTED THAT HER BROTHER HAD FALLEN ON (B)(6) 2012 DUE TO LOW BLOOD GLUCOSE AND BROKE HIS JAW. HE HAD BEEN WORKING ON HIS ROOF ALL DAY AND HAD ALSO STEPPED ON A NAIL. WHEN SHE CAME HOME SHE FOUND HIM UNCONSCIOUS ON THE FLOOR. SHE TESTED HIS BLOOD GLUCOSE LEVEL AND IT WAS READ LOW. SHE GAVE HIM AN INJECTION OF GLUCAGON AND HE REGAINED CONSCIOUSNESS 10-15 MINUTES LATER. SHE THEN GAVE HIM JUICE. ONCE HE WAS FEELING BETTER SHE HELPED HIM CHANGE HIS CLOTHES AND DROVE HIM TO THE HOSPITAL. HE DID NOT RECEIVE TREATMENT FOR LOW BLOOD GLUCOSE WHILE AT THE HOSPITAL. HE WAS TREATED FOR HIS JAW AND THE NAIL PUNCTURE ONLY. AFTER THE INCIDENT THE PATIENT BEGAN USING HIS NEW INFUSION DEVICE. THE PATIENT DID NOT MAKE ANY ALLEGATIONS AGAINST THE PERFORMANCE OF THE INFUSION DEVICE HE HAD BEEN USING. THE PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS 180 MG/DL. THE PATIENT HAS BEEN UNDER AN INCREASED AMOUNT OF STRESS. THE PATIENT STATED THAT HIS BLOOD GLUCOSE LEVEL DROPS WHEN HE WORKS AND DURING THE DAY OF THE INCIDENT HE WENT INSIDE TO EAT LUNCH AROUND 11:00 AM TO BRING HIS BLOOD GLUCOSE LEVEL UP. HE STOPPED AROUND 4:00-5:00PM AND WENT INSIDE TO EAT DINNER. THE PATIENT WENT TO BED EARLY AND WOKE UP AROUND 12:00AM. HE WAS SWEATY AND WAS TRYING TO GET OUT OF BED AND THAT WAS THE LAST THING HE REMEMBERED. THE PATIENT'S SISTER CALLS HIM AT 3:00AM EVERY DAY, WHEN HE DID NOT ANSWER SHE WENT TO HIS HOUSE TO CHECK ON HIM. THE INFUSION DEVICE WAS NOT REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16881 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUATIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R DATES OF THERAPY: UNK| RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN