BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 1903446 · Received November 12, 2010

    Report

    Report Number
    2183996-2010-02310
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 20, 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 EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS SINCE (B)(6) 2010. PATIENT STATED HIS BLOOD GLUCOSE LEVEL HAS BEEN UP TO 400 MG/DL. PATIENT REPORTED HE TOOK CORRECTION VIA THE PEN. PATIENT REPORTED ON (B)(6) 2010 AT 8:00 PM, HE HAD TO BE DRIVEN TO THE HOSPITAL BY AMBULANCE. PATIENT STATED HE STOPPED USING THE INFUSION DEVICE AT THAT TIME. PATIENT REPORTED ON (B)(6) 2010 HE SWITCHED TO THE BACKUP INFUSION DEVICE AND HIS BLOOD GLUCOSE LEVEL BECAME OKAY. NO NORMAL BLOOD GLUCOSE LEVEL WAS PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. 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 D-TRONPLUS INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R INSULIN INFUSION SET| INSULIN