BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2250038 · Received September 9, 2011

    Report

    Report Number
    2032227-2011-02284
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 DUE TO LOW BLOOD GLUCOSE LEVELS. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 109 MG/DL. IT WAS STATED THAT THE CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS FOR THE PAST THREE HOURS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME WAS ALSO CORRECT. THE INSULIN PUMP PASSED THE SELF TEST. THE CALLER ALSO REPORTED THAT THE INSULIN PUMP WAS SUBMERGED IN WATER. IT WAS STATED THAT THE CUSTOMER DID NOT WANT A REPLACEMENT AT THIS TIME, AND WOULD BE CALLING BACK AS HE WILL BE CONSIDERING UPGRADING. 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-515LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization