BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2162169 · Received July 7, 2011

    Report

    Report Number
    2183996-2011-02001
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 4, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTED 1.5 WEEKS PRIOR TO THE INCIDENT; SHE NOTICED THE PATIENT'S BLOOD GLUCOSE LEVELS WERE HIGHER THAN NORMAL. MOTHER STATED THE PATIENT HAS A LOT OF HYPOGLYCEMIA, BUT SINCE 1.5 WEEKS AGO, THE PATIENT HAS HAD MORE HYPERGLYCEMIA. MOTHER REPORTED SHE THOUGHT THIS WAS STRANGE. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 7.0-13.0 MMOL/L (126-234 MG/DL). MOTHER REPORTED THE PATIENT WENT FOR A SLEEP OVER AND ON (B)(6) 2011 THE PATIENT'S EVENING BLOOD GLUCOSE LEVEL WAS 27.0 MMOL/L (486 MG/DL). MOTHER STATED THE PATIENT HAD 3+ KETONES AND WAS GIVEN A BOLUS OF 4.0 UNITS OF INSULIN BY PEN AND A BOLUS VIA THE INFUSION DEVICE. MOTHER REPORTED THE FRIEND'S MOTHER CALLED THE EMERGENCY DOCTOR AT THE HOSPITAL WHO ADVISED THE TREATMENT CORRECTION FOR THE PATIENT. MOTHER STATED THE PATIENT'S CORRECTION WAS GIVEN BY THE FRIEND'S MOTHER AND THE PATIENT'S BLOOD GLUCOSE LEVEL RETURNED TO NORMAL AFTER THE BOLUS. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention INSULIN INFUSION SET| INSULIN