BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2012984 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00426
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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 INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT'S DIET COUNSELOR REPORTED THE PATIENT'S BLOOD GLUCOSE MEASURED 579 MG/DL AT 9:30 PM ON (B)(6) 2011. THE PATIENT ADMINISTERED SEVERAL BOLUSES THROUGH THE INFUSION DEVICE. ON (B)(6) 2011, THE PATIENT VISITED HIS DIABETES SPECIALIST AND AT 9:15 AM HIS BLOOD GLUCOSE MEASURED 275 MG/DL. THE PATIENT HAD SYMPTOMS OF SHIVERING AND ABDOMINAL PAIN. THE PATIENT BEGAN USE OF A REPLACEMENT INFUSION DEVICE. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED 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 46 YR INSULIN INFUSION SET| INSULIN