BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3092923 · Received May 3, 2013

    Report

    Report Number
    2032227-2013-01634
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 CALLED TO REPORT THAT SHE SOMETIMES EXPERIENCES BLOOD GLUCOSE LEVELS GREATER THAN 600 MG/DL. THE CUSTOMER'S BLOOD GLUCOSE THIS MORNING WAS GREATER THAN 400 MG/DL. SHE FELT SICK TO HER STOMACH AND HAD ABDOMINAL PAIN. THE CUSTOMER THEN STATED THAT SHE WAS TREATED AT HOME BY THE PARAMEDICS DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS NOT FEELING WELL THAT MORNING, AND PRESSED HER LIFE ALERT BUTTON. WHEN THE PARAMEDICS ARRIVED, SHE WAS UNCONSCIOUS AND HAD A BLOOD GLUCOSE OF 25 MG/DL. THE CUSTOMER TREATED WITH MILK, AND REFUSED TO GO TO THE HOSPITAL. THE CUSTOMER ALSO REPORTED A VERY SCRATCHED LCD SCREEN AND NOT BEING ABLE TO READ IT BECAUSE OF THE SCRATCHES. ADVISED THE CUSTOMER OF HER OUT OF WARRANTY OPTIONS, AND ADVISED THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194529 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention