BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2870072 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-07982
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 22, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 215 MG/DL. IT WAS ALSO STATED THAT THE INSULIN PUMP HAD A CRACK ON THE RESERVOIR COMPARTMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP LZG LZG MEDTRONIC MINIMED MMT-512LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization