BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1870132 · Received October 12, 2010

    Report

    Report Number
    2183996-2010-02100
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED HIS BLOOD GLUCOSE READINGS HAVE INCREASED DRASTICALLY. PATIENT STATED HE HAS BEEN EXPERIENCING HIGHER THAN NORMAL READINGS OVER THE PAST WEEK. PATIENT REPORTED RECEIVING A READING OF 23.0 MMOL/L (414 MG/DL) ON (B)(6) 2010, SO HE BOLUSED 8.0 UNITS OF INSULIN AND TESTED 3 HOURS LATER WITH A READING OF 17.0 MMOL/L (306 MG/DL). PATIENT STATED HE ATTEMPTED TO BOLUS AGAIN, BUT IT TOOK THE ENTIRE DAY TO BRING HIS READINGS BACK DOWN. PATIENT REPORTED HE DIDN'T EAT ANY FOOD ALL DAY AND HIS READINGS NEVER FELL BELOW 11.0 MMOL/L (198 MG/DL). PATIENT STATED HE RECEIVED A READING OF 10.0 MMOL/L TODAY SO HE BOLUSED 2.0 UNITS OF INSULIN AND TESTED 2 HOURS LATER WITH A READING OF 11.5 MMOL/L (207 MG/DL). PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 5-7 MMOL/L (90-126 MG/DL). PATIENT REPORTED NO LIFESTYLE CHANGES EXCEPT FOR A LOSS IN WEIGHT. PATIENT STATED HE WAS NOT HAVING THESE ISSUES WHEN HE WAS USING THE BACKUP INFUSION DEVICE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention INSULIN INFUSION SET| INSULIN