BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 1983812 · Received January 20, 2011

    Report

    Report Number
    2183996-2010-02784
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 21, 2010
    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 REPORTED THAT ON (B)(6) 2010 AT 7:00AM, HER BLOOD GLUCOSE MEASURED 268 MG/DL AND SHE BOLUSED 3 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. SHE ATE AND BOLUSED 13.5 UNITS OF INSULIN. AT 11:00AM, SHE FELT VERY SICK AND HER BLOOD GLUCOSE WAS OVER 600 MG/DL. SHE BOLUSED THROUGH THE INFUSION DEVICE AND INJECTED INSULIN VIA SYRINGE. SHE INSPECTED THE INFUSION SET AND PROGRAMMED A 1 UNIT BOLUS AND NO INSULIN DRIPPED FROM THE END OF THE NEEDLE. SHE PROGRAMMED A 2 UNIT BOLUS AND BLOOD CAME OUT OF THE NEEDLE. SHE CHANGED THE HEADSET AND BOLUSED THROUGH THE INFUSION DEVICE. SHE STATED THE INFUSION DEVICE DID NOT PROPERLY DISPLAY E4 (OCCLUSION) ERROR. 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 D-TRONPLUS INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR INSULIN| INSULIN INFUSION SET