BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4160235 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25942
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED HIGH BLOOD GLUCOSE AND IT DECREASED AFTER GIVING AN INSULIN INJECTION. IT WAS STATED THAT THE INSULIN PUMP WAS DISCONNECTED A FEW WEEKS AGO AND WAS RECONNECTED ON THE LAST FEW DAYS. NO DELIVERY ALARMS FOUND IN THE ALARM HISTORY. THE DRIVE SUPPORT CAP IS NORMAL. INSULIN PUMP CAN BE REWOUND. AND MANUAL PRIME CAN BE PERFORMED SUCCESSFULLY. DEVICE PASSED THE HIGH PRESSURE TEST. TIME, DATE, BASAL RATES AND BOLUS WIZARD ARE CORRECT. IT WAS STATED THAT THE INFUSION SET BUT PROBLEM PERSIST. LAST CANNULA WAS NOT BENT AND THE INSULIN IS NOT EXPIRED. IT WAS STATED THAT THE BLOOD GLUCOSE GOES HIGH EVERY TIME THE CUSTOMER CONNECTS TO THE INSULIN PUMP. CUSTOMER WAS OFFERED TO GET THE DEVICE REPLACED AND CUSTOMER DECLINED. BLOOD GLUCOSE VALUE IS 160 MG/DL/ NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581580 PARADIGM INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715WWS

    Patients

    Seq Age Sex Outcome Treatment
    1