BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2032297 · Received March 22, 2011

    Report

    Report Number
    2032227-2011-00718
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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

    THE CUSTOMER CALLED TO REPORT A HIGH BLOOD GLUCOSE READING OF 521 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY EXCEPT FOR THE TIME, WHICH WAS OFF BY AN HOUR. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DIDN'T HAVE A TUBING CLAMP FOR THE HIGH PRESSURE TEST. DURING THE CALL, THE CUSTOMER'S BLOOD GLUCOSE LEVELS ROSE TO 583 MG/DL, AND THE PARAMEDICS WERE CALLED. THE PARAMEDICS ARRIVED, BUT THE CUSTOMER DID NOT WANT TO BE HOSPITALIZED. 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 MINIMED MMT-715LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention