BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202320 · Received August 2, 2011

    Report

    Report Number
    2032227-2011-01898
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 18, 2010
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE CUSTOMER STATED THAT HE DOES NOT REMEMBER THE TIME AND DATE OF HIS ADMISSION. THE CUSTOMER STATED THAT THE BLOOD GLUCOSE READING WAS 1000MG/DL. THE CUSTOMER STATED THAT THE TUBING OF HIS INFUSION SET WAS CHEWED IN HALF BY HIS PUPPY. TROUBLESHOOTING WAS DECLINED, AND THE CUSTOMER STATED THAT HIS INSULIN PUMP WAS FUNCTIONING PROPERLY. NO FURTHER INFO WAS PROVIDED.

    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-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization