BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2041781 · Received March 29, 2011

    Report

    Report Number
    3004209178-2011-80836
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 2, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH HYPERGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 221 MG/DL. THE OFFICIAL CAUSE OF HOSPITALIZATION WAS FOR DIABETES MANAGEMENT. THE INSULIN PUMP TRAINER STATED THAT THE INSULIN PUMP WAS UNRELATED TO THE HOSPITALIZATION AND THE CUSTOMER'S LAST BLOOD GLUCOSE READING WAS 110 MG/DL. THE INSULIN PUMP TRAINER ALSO STATED THAT SOME OF THE BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. 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 PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization