BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 1760225 · Received July 12, 2010

    Report

    Report Number
    2183996-2010-01409
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 12, 2010
    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. 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 THAT ON (B)(6) 2010, HER BLOOD GLUCOSE ELEVATED TO OVER 300 MG/DL AND SHE BOLUSED THROUGH THE INFUSION DEVICE. SHE STATED THAT 1-2 HOURS LATER HER BLOOD GLUCOSE INCREASED AND AT 10:00PM MEASURED 279 MG/DL AND SHE BOLUSED THROUGH THE INFUSION DEVICE. DURING THE NIGHT E7 (ELECTRONIC) ERROR WAS DISPLAYED ON THE DEVICE AND SHE REMOVED THE POWER PACK AND INJECTED INSULIN VIA PEN. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE 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 59 YR INSULIN| INSULIN INFUSION SET