BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3883707 · Received June 19, 2014

    Report

    Report Number
    2032227-2014-03089
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 RETURN FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2014-02114.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY CALLED STATING THAT HER INSULIN PUMP IS MALFUNCTIONING. CUSTOMER STATED THAT SHE HAD THE TROUBLE WITH THE INSULIN PUMP FOR A FEW MONTHS. CUSTOMER MENTIONED THAT SHE WAS IN AND OUT OF THE HOSPITAL DUE TO HIGH AND LOW BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359906 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization