BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1893628 · Received November 4, 2010

    Report

    Report Number
    2183996-2010-02228
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    August 15, 2010
    Report Date
    October 7, 2010
    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
    GM
    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 INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT'S MOTHER REPORTED, THE PT HAS EXPERIENCED LOW BLOOD GLUCOSE LEVELS SINCE THE MIDDLE OF (B)(6) 2010. MOTHER REPORTED, THE PT'S BLOOD GLUCOSE HAS GONE AS LOW AS 29 MG/DL. MOTHER STATED, SHE SPOKE WITH THE PT'S DIABETES SPECIALIST ON (B)(6) 2010 AND SHE STATED, HE THINKS, THE INFUSION DEVICE IS DELIVERING TOO HIGH OF AN AMOUNT OF INSULIN. MOTHER REPORTED, THE PT EXPERIENCED A BLOOD GLUCOSE LEVEL OF 61 MG/DL ON (B)(6) 2010, ATE 3.5 CARBOHYDRATE UNITS AND ADMINISTERED 2.5 UNITS OF INSULIN VIA THE INFUSION DEVICE. MOTHER STATED, THE PT RECEIVED, A BLOOD GLUCOSE LEVEL OF 29 MG/DL AT 9:15 AM, AT 4.0 CARBOHYDRATE UNITS AND ADMINISTERED 1.0 UNIT OF INSULIN VIA THE INFUSION DEVICE. MOTHER REPORTED THAT ON (B)(6) 2010 AT 5:00-6:30 PM, THE PT PLAYED FOOTBALL AND AT 7:15 PM HIS BLOOD GLUCOSE LEVEL WAS 187 MG/DL: PT ATE 2.6 CARBOHYDRATE UNITS AND ADMINISTER 2.6 UNITS OF INSULIN VIA THE INFUSION DEVICE. MOTHER STATED, THE PT HAD A BLOOD GLUCOSE READING OF 75 MG/DL AT 11:00 PM AND THEN SHE PROGRAMMED A TEMPORARY BASAL RATE (TBR) OF 80% VIA THE INFUSION DEVICE. PT'S NORMAL BLOOD GLUCOSE LEVEL IS 70/120 MG/DL. MOTHER REPORTED, PT USES THE INFUSION SET FOR 2 DAYS AND THE INFUSION TUBING FOR 14 DAYS. ADVISED MOTHER OF RECOMMENDATION FOR INFUSION TUBING USE. NO FURTHER INFO IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    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 8 YR Required Intervention INSULIN| INSULIN INFUSION SET