BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2142315 · Received June 20, 2011

    Report

    Report Number
    2032227-2011-01503
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 20 MG/DL. THE CUSTOMER HAD EXPERIENCED LOW BLOOD GLUCOSE LEVELS FOR THE PAST DAY, AND WAS SHAKY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. IT WAS STATED THAT THE CUSTOMER MAY HAVE OVER BOLUSED. DAYS LATER, A DIABETES EDUCATOR CALLED TO REQUEST A REPLACEMENT INSULIN PUMP. SHE STATED THAT THE CUSTOMER CONTINUED TO EXPERIENCE LOW BLOOD GLUCOSE LEVELS IN THE HOSPITAL, WHILE WEARING THE INSULIN PUMP. THE CUSTOMER WAS PUT ON A DIFFERENT INSULIN PUMP, AND DID NOT EXPERIENCE LOW BLOOD GLUCOSE LEVELS AFTER THAT. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization