BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2253772 · Received August 10, 2011

    Report

    Report Number
    2183996-2011-02208
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    June 29, 2011
    Report Date
    August 2, 2011
    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. 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

    MOTHER REPORTED THE CHECK BUTTON ON THE INFUSION DEVICE WAS DAMAGED ON (B)(6) 2011. PT CONTINUED TO USE THE INFUSION DEVICE FOR 2 DAYS AND THEN SWITCHED TO THE BACKUP INFUSION DEVICE. BLOOD GLUCOSE ELEVATED AS HIGH AS 300 MG/DL, AND PT WAS ABLE TO CONTROL HER BLOOD GLUCOSE BY HERSELF. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO ADD'L INFO WAS PROVIDED.

    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 13 YR INSULIN INFUSION SET| INSULIN