BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 1872029 · Received October 8, 2010

    Report

    Report Number
    2183996-2010-02088
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 27, 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 INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED ONGOING HYPERGLYCEMIA. BLOOD GLUCOSE ELEVATED TO 408 MG/DL ON (B)(6) 2010. PATIENT CHANGED INFUSION SET AND DELIVERED A CORRECTION BOLUS BY INFUSION DEVICE, BUT THIS DID NOT LOWER BLOOD GLUCOSE. PATIENT THEN DELIVERED A CORRECTION BOLUS BY INSULIN INJECTION AND THIS WAS SUCCESSFUL. PATIENT CHANGED THE ADAPTER, INFUSION SET, AND INSULIN CARTRIDGE ON (B)(6) 2010 AT 7:00 A.M. INFUSION DEVICE STARTED AS NORMAL BUT DISPLAYED A4 CARTRIDGE/ADAPTER ALERT. PATIENT WAS UNABLE TO CLEAR THIS ALERT. PATIENT SWITCHED TO BACKUP INFUSION DEVICE AT 8:40 P.M. AT TIME OF REPORT, BLOOD GLUCOSE LEVEL WAS NORMAL AND BACKUP INFUSION DEVICE WAS FUNCTIONING PROPERLY. PATIENT CHANGES INFUSION NEEDLE EVERY 2 DAYS AND TUBING AND INSULIN CARTRIDGE EVERY 8-9 DAYS. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. PATIENT DID NOT LOSE CONSCIOUSNESS OR SPILL KETONES. INFUSION DEVICE WAS REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 Required Intervention INSULIN| INSULIN INFUSION SET