BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3083558 · Received April 29, 2013

    Report

    Report Number
    2032227-2013-01567
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WENT TO THE EMERGENCY ROOM DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE OF 685 MG/DL. THE CUSTOMER INSPECTED THE DRIVE SUPPORT CAP, AND IT APPEARED TO BE FLUSH, BUT NOT PROTRUDING FROM THE CASE. ADVISED THE CUSTOMER OF HIS OUT OF WARRANTY OPTIONS, AND EXPLAINED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184068 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization