BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 1993755 · Received January 26, 2011

    Report

    Report Number
    2183996-2011-00065
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 13, 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
    NL
    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 EXPERIENCING ELEVATED BLOOD GLUCOSE OF 9-17 MMOL/L (162-306 MG/DL) SINCE THE BEGINNING OF (B)(6) 2010. HER NORMAL BLOOD GLUCOSE RANGE IS 4-6 MMOL/L (72-108 MG/DL). SHE CONTACTED HER DIABETES NURSE AND WAS ADVISED TO DELIVER ADDITIONAL BOLUSES. SHE WAS UNABLE TO LOWER HER BLOOD GLUCOSE BY DELIVERING ADDITIONAL BOLUSES. THE PATIENT DISCONTINUED USE OF THE INFUSION DEVICE AND HER BLOOD GLUCOSE DECREASED THE SAME DAY. IT IS UNKNOWN IF THE PATIENT SWITCHED TO A BACKUP INFUSION DEVICE OR INJECTED INSULIN VIA SYRINGE. NO FURTHER INFORMATION IS AVAILABLE. 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 81 YR INSULIN INFUSION SET| INSULIN