BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2062698 · Received April 12, 2011

    Report

    Report Number
    3004209178-2011-81010
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. 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 TREATED BY HER DOCTOR FOR HYPERGLYCEMIA. THE CUSTOMER STATED THAT SHE HAD BEEN HAVING PROBLEMS WITH ELEVATED BLOOD GLUCOSE LEVELS. THE CUSTOMER'S PERCEIVED CAUSE OF EVENT WAS AN ISSUE WITH THE INSULIN PUMP. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE FIXED PRIME TEST. NOTHING FURTHER WAS REPORTED.

    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-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention