BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2012110 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00386
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 18, 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

    THE PT REPORTED, THE INFUSION DEVICE DOES NOT PROPERLY DISPLAY ALERT/ERROR MESSAGES. A TEMPORARY BASAL RATE INCREASE OF 110% WAS PROGRAMMED FOR A DURATION OF 1 HOUR AND NO A7 (END OF TEMPORARY BASAL RATE) ALARM WAS DISPLAYED. ACCORDING TO THE INFUSION DEVICE SOFTWARE, THE TEMPORARY BASAL RATE WAS PROGRAMMED FOR 11 HOURS. ANOTHER TEMPORARY BASAL RATE OF 140% WAS PROGRAMMED FOR 1 HOUR AND AGAIN THE INFUSION DEVICE SOFTWARE SHOWED IT HAD BEEN PROGRAMMED FOR 11 HOURS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND 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 43 YR INSULIN| INSULIN INFUSION SET