BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2182524 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-82200
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    IT WAS REPORTED THAT THE CUSTOMER OVER DELIVERED APPROX 80.0 UNITS OF INSULIN AND HIS BLOOD GLUCOSE WAS 148MG/DL. IT WAS STATED THAT THE INSULIN PUMP WAS NOT REWOUND BEFORE INSERTING A NEW FILLED RESERVOIR, AND HE WAS ALSO CONNECTED TO HIS BODY AT THE TIME. IT WAS STATED THAT HIS GLUCOSE LEVEL DROPPED TO 55MG/DL IN SHORT PERIOD OF TIME. THE MOTHER STATED THAT THEY WERE IN THEIR WAY TO THE HOSPITAL. LATER, THE MOTHER CALLED BACK AND STATED THAT THE CUSTOMER WAS TAKEN TO THE HOSPITAL AND HE WAS DISCHARGED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization