BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2142873 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-81887
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. 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 FOR HIGH BLOOD GLUCOSE AND KETONES. IT WAS STATED THAT THE CUSTOMER WOKE UP BEING SICK AND THE GLUCOSE READING WAS 24.9 MMOL/L. IT WAS STATED THAT THE CUSTOMER TREATED WITH AN INSULIN PEN. IT WAS STATED THAT THE CUSTOMER CHANGED THE INFUSION SET THE DAY BEFORE THE EVENT. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER BOLUSED AND RECEIVED A NO DELIVERY ALARM. IT WAS STATED THAT THE CUSTOMER CHANGES THE INFUSION SETS EVERY THREE DAYS. RAN A FIXED PRIME AND INSULIN EXITED. PERFORMED A SELF TEST AND THE TEST PASSED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization