BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1905770 · Received November 16, 2010

    Report

    Report Number
    2183996-2010-02352
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 2, 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
    AS
    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 REPORTED HER INFUSION DEVICE IS LEAKING FROM THE INFUSION ADAPTER. PATIENT STATED SHE HAD A FEW ELEVATED BLOOD GLUCOSE READINGS OF 25.0-26.0 MMOL/L (450-468 MG/DL) FROM (B)(6) 2010-(B)(6) 2010. PATIENT REPORTED SHE THOUGHT SHE WAS GETTING A COLD OR THE FLU SO SHE DID NOT THINK THERE WAS A PROBLEM. PATIENT STATED SHE GAVE HERSELF AN INSULIN INJECTION TO BRING THE BLOOD GLUCOSE LEVELS DOWN. PATIENT REPORTED SHE NOTICED THERE WAS AN INSULIN LEAK COMING FROM THE INFUSION ADAPTER ON (B)(6) 2010. PATIENT STATED SOMEWHERE AROUND THE INFUSION ADAPTER IS LEAKING. PATIENT REPORTED SHE IS NOT SURE IF IT IS THE INFUSION ADAPTER ITSELF OR AROUND THE LUER LOCK. PATIENT STATED SHE CHANGED THE INFUSION ADAPTER, LUER LOCK, INFUSION SET AND INSULIN CARTRIDGE BUT THE ISSUE PERSISTED. PATIENT REPORTED SHE HAS BEEN GIVING HERSELF INSULIN INJECTIONS MANUALLY SINCE (B)(6) 2010. 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 26 YR Required Intervention INSULIN INFUSION SET| INSULIN