BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2253722 · Received August 10, 2011

    Report

    Report Number
    2183996-2011-02226
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 27, 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
    IT
    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

    PT REPORTED THE INFUSION DEVICE DOESN'T WORK PROPERLY BECAUSE HE HAS ELEVATED BLOOD GLUCOSE LEVELS UP TO 400 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 90-100 MG/DL. PT STATED THE ISSUE BEGAN IN (B)(6) 2010 WHEN THE INFUSION DEVICE GAVE AN A7 (TEMPORARY BASAL RATE OVER) ALARM W/O HAVING SET ANY TEMPORARY BASAL RATE. PT REPORTED HE CLEARED THE ALARM, CHANGE THE BATTERY AND THE ALARM DISAPPEARED. PT SWITCHED TO THE BACKUP INFUSION DEVICE UNTIL (B)(6) 2011. PT STATED HE DID NOT HAVE ANY ISSUES WITH HYPERGLYCEMIA WHILE ON THE BACKUP INFUSION DEVICE. PT REPORTED ON (B)(6) 2011 HE SWITCHED BACK TO THE PRIMARY INFUSION DEVICE AND HAD NO PROBLEMS UNTIL 2 WEEKS AGO WHEN HE BEGAN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS UP TO 400 MG/DL. PT STATED EVERY TIME HE FELT A LITTLE FOREWARNING OF HIS GLUCOSE LEVEL RISING, HE WAS ABLE TO KEEP THE SITUATION UNDER CONTROL. PT REPORTED HIS BLOOD GLUCOSE LEVELS INCREASED, ESPECIALLY DURING THE AFTERNOON AND DURING THE NIGHT. PT STATED HE HAD TO WAKE UP MANY TIMES TO DELIVER A BOLUS. PT REPORTED HE SWITCHED TO THE BACKUP INFUSION DEVICE AGAIN ON YESTERDAY AND THIS MORNING HE WOKE UP WITH A PERFECT BLOOD GLUCOSE LEVEL. PT STATED HE DIDN'T NEED TO GO TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT 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 INSULIN INFUSION SET| INSULIN