BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-TRONPLUS

    MDR report key: 1241791 · Received November 20, 2008

    Report

    Report Number
    2183996-2008-01762
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 11, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K022831
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED ELEVATED BLOOD GLUCOSE READINGS OF 16 MMOL/L (288 MG/DL) AND 14.7 MMOL/L (264.6 MG/DL). HER NORMAL RANGE IS 4-6 MMOL/L (72-108 MG/DL). SHE STATED SHE DOES NOT BELIEVE HER INSULIN INFUSION DEVICE IS PROPERLY DELIVERING HER BASAL RATE AS SHE CAN CORRECT HER ELEVATED READINGS WITH A BOLUS BUT SHE HAS TO GIVE MORE OF A BOLUS THAN SHE USED TO. DURING TROUBLESHOOTING, THE PATIENT STATED SHE CHANGES HER INFUSION HEADSET ON WEDNESDAYS AND HER HEADSET AND TUBING ON SUNDAYS. SHE WAS ADVISED TO CHANGE HER HEADSET EVERY 3 DAYS AND THE TUBING EVERY 6 DAYS. ON FOLLOW UP ON THREE DAYS LATER, THE PATIENT WAS NOT AVAILABLE BUT THE PERSON WHO ANSWERED STATED, THE PATIENT IS USING HER NEW INFUSION DEVICE AND HER BLOOD GLUCOSE LEVELS HAVE RETURNED TO NORMAL. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-TRONPLUS INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention INSULIN| INSULIN INFUSION SET