BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2161156 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01644
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE CUSTOMER STATED THAT THE RESERVOIR WAS EMPTY, AND SHE HAD NOT REALIZED IT. TROUBLESHOOTING WAS NOT POSSIBLE DUE THE BATTERY CAP BEING LOST DURING THE HOSPITALIZATION. ADVISED THE CUSTOMER THAT A REPLACEMENT BATTERY CAP WOULD BE SENT TO HIM. 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-512NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization