BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2082791 · Received April 28, 2011

    Report

    Report Number
    3004209178-2011-81268
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 STATED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE AND PARAMEDICS WERE CALLED BY THE SCHOOL NURSE AS HIS BLOOD GLUCOSE WAS IN THE 300'S MG/DL. THE PARAMEDICS TREATED THE CUSTOMER AT THE SCHOOL AND SENT HIM HOME. IT WAS STATED THAT THE INSULIN WAS STORED IN THE CAR OVERNIGHT. ADVISED MOTHER TO CALL THE INSULIN MFR TO MAKE SURE THAT THE INSULIN IS STILL GOOD. TROUBLESHOOTING WAS PERFORMED. THE TIME ON THE DEVICE WAS CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE TEST PASSED. THE MOTHER STATED THAT THE SETTINGS MAY HAVE TO BE ADJUSTED AND HIS DOCTOR WAS CONTACTED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization