BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4103830 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26710
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EMPTY INSULIN PUMP ALARMED NO DELIVERY. IN THE ALARM HISTORY THERE WERE MORE NO DELIVERY ALARMS PRESENT. IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS NORMAL AND THEY DID NOT REQUIRE MEDICAL TREATMENT. NO SPECIFIC VALUE WAS PROVIDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582258 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712WWB

    Patients

    Seq Age Sex Outcome Treatment
    1