BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090022 · Received May 4, 2011

    Report

    Report Number
    3004209178-2011-81332
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    June 3, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP OVER DELIVERED WHILE BEING ON VACATION LAST YEAR. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO WATER AND THEN THE DEVICE ALARMED MOTOR ERROR. THE INSULIN PUMP WAS REPLACED AT THAT TIME. RECENTLY, THE CUSTOMER SEND AN E-MAIL AND STATED THAT THE INSULIN PUMP GAVE HIM 100 UNITS OF INSULIN WHILE WALKING TO HIS HOTEL ROOM. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE READING WAS 218MG/DL AT THIS POINT, AND SHORTLY AFTER HIS GLUCOSE LEVEL WENT DOWN TO 60MG/DL. THE PARAMEDICS WERE CALLED AND CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM. THE CUSTOMER STATED THAT HE WAS RELEASED THE SAME DAY AFTER HIS BLOOD GLUCOSE WAS STABLE. THE INSULIN PUMP WAS WITHOUT A BATTERY AND TROUBLESHOOTING WAS NOT PERFORMED. THE CUSTOMER IS KEEPING THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization