BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2202480 · Received August 5, 2011

    Report

    Report Number
    2183996-2011-02162
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL. THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    FATHER REPORTED THAT PT HAS BEEN HOSPITALIZED SINCE (B)(6) 2011 DUE TO VARYING BLOOD GLUCOSE LEVELS OVER A LONG PERIOD OF TIME. DURING THE HOSPITALIZATION, PT EXPERIENCED A HYPOGLYCEMIC EVENT AND RECEIVED GLUCAGON. PT IS STILL IN THE HOSP AS FURTHER EXAMINATIONS ARE NEEDED FOR A METABOLIC DISORDER. PT REMAINS ON PUMP THERAPY WHILE IN THE HOSP. FATHER WAS OFFERED A REPLACEMENT INFUSION DEVICE FOR THE PT, BUT HE DECLINED. HE DOES NOT DOUBT THE INFUSION DEVICE FUNCTIONS CORRECTLY. NO PRODUCT WILL BE RETURNED FOR EVAL. NO ADD'L INFO WAS PROVIDED.

    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 15 YR Hospitalization| R INSULIN INFUSION SET (DATE OF TX: (B)(6) - UNK)| INSULIN (DATE OF TX: (B)(6) 2011 - UNK)