BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 1890046 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02194
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 5, 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
    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 EXPERIENCED HYPERGLYCEMIA AND "GOT IN A COMA." WIFE DELIVERED INSULIN INJECTION WITH A PEN TO DECREASE BLOOD GLUCOSE. NORMAL BLOOD GLUCOSE IS BETWEEN 5-8 MMOL/L. INFUSION DEVICE WAS NOT EXPOSED TO ELECTROMAGNETIC FIELDS. NO ERROR MESSAGES WERE RECEIVED ON INFUSION DEVICE. PATIENT DID NOT REQUIRE TREATMENT AT A HOSPITAL. PATIENT WAS NOT EXPERIENCING HEALTH CONCERNS OR STRESS AND THERE WERE NO CHANGES TO ACTIVITY OR MEDICINE. PATIENT'S EATING PATTERNS WERE NORMAL. INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention INSULIN INFUSION SET| INSULIN