BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2193312 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-82279
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    April 14, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 276MG/DL. THE MOTHER STATED THAT THE CUSTOMER'S HIGH GLUCOSE WAS DUE TO LACK OF KNOWLEDGE AND MALFUNCTIONING OF THE INSULIN PUMP. IT WAS STATED THAT THE CUSTOMER RECENTLY WAS IN AN ACCIDENT, AND SHE IS IN A LOT OF PAIN WHILE ON THE CALL. THE MOTHER STATED THAT THE BATTERY COMPARTMENT IS STRIPPED. ADVISED THE MOTHER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK UP PLAN. NO FURTHER INFORMATION 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 PUERTO RICO OPERATIONS MED-REL MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization