BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2232496 · Received August 25, 2011

    Report

    Report Number
    2183996-2011-02324
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    June 6, 2011
    Report Date
    August 19, 2011
    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 U.S. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT EXPERIENCED LOW BLOOD GLUCOSE OF 2.8 MMOL/L (50 MG/DL) WHILE DRIVING. HE STOPPED AND ATE A PIECE OF GLUCOSE AND FELT SLIGHTLY BETTER. A SHORT TIME LATER HE ¿FEEBLE¿ AND WRECKED HIS CAR. FURTHER DETAILS REGARDING THE CAR ACCIDENT AND TREATMENT PROVIDED TO THE PT ARE NOT AVAILABLE. ON (B)(6) 2011, THE PT FOUND THE DISPLAY OF THE INFUSION DEVICE WAS DEFECTIVE DESPITE CHANGING THE POWER PACK. HE SWITCHED TO THE BACKUP INFUSION DEVICE. THE CAR ACCIDENT WAS REPORTED BY THE PT¿S INSURANCE COMPANY ON (B)(6) 2011. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVAL.

    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 53 YR Required Intervention INSULIN INFUSION SET| INSULIN