BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2332222 · Received November 2, 2011

    Report

    Report Number
    2183996-2011-02746
    Event Type
    Injury
    Date Received
    November 2, 2011
    Date of Event
    January 1, 1998
    Report Date
    October 31, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K022831
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED EXPERIENCING A LOW BLOOD GLUCOSE EVENT WHILE USING A PREVIOUS INFUSION DEVICE. PT STATED, THE EVENT OCCURRED IN 1998. PT REPORTED, HE DOES NOT RECALL MUCH INFORMATION ABOUT THE EVENT. PT STATED, HE WAS DRIVING A BUS AND HAD SKIPPED HIS MEALS ALL DAY DUE TO HIS WORK SCHEDULE. PT REPORTED, HE NOTICED HE HAD BLURRY VISION SO HE PULLED OVER AND CALLED HIS DISPATCHER WHO IN TURN CALLED THE EMTS. PT STATED WHEN THE EMTS ARRIVE, HE WAS UNCONSCIOUS. PT REPORTED, HE WAS GIVEN A GLUCAGON SHOT AND GLUCOSE PASTE. PT STATED, HIS BLOOD GLUCOSE LEVEL WAS TESTED WHEN THE EMTS ARRIVED WITH A RESULT OF 30 MG/DL. PT REPORTED, HE REGAINED CONSCIOUSNESS ON THE WAY TO THE HOSPITAL. PT STATED, HIS BLOOD GLUCOSE LEVEL WAS 170 MG/DL BY THE TIME HE ARRIVED AT THE ER. PT'S NORMAL BLOOD GLUCOSE RANGE IS 150-190 MG/DL. PT REPORTED, HE WAS NOT ADMITTED AND WAS SENT HOME. INFUSION DEVICE HAS ALREADY BEEN RETURNED AND UPGRADED.

    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 44 YR Hospitalization| R INSULIN| INSULIN INFUSION SET