BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2121446 · Received June 7, 2011

    Report

    Report Number
    2032227-2011-01374
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER CHANGED THE INFUSION SET PRIOR TO THE EVENT, AND WOKE UP VOMITING WITH A BLOOD GLUCOSE OF 20 MMOL/L. THE CUSTOMER CHANGED THE INFUSION SET AGAIN AND NOTICED BLOOD IN THE TUBING. THE NEXT MORNING, THE CUSTOMER AGAIN EXPERIENCED VOMITING AND A BLOOD GLUCOSE OF 20 MMOL/L. THE CUSTOMER ALSO GOT A NO DELIVERY ALARM. 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-512LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SET: MMT-397.| UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION