BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2070227 · Received April 18, 2011

    Report

    Report Number
    2032227-2011-00951
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 26, 2011
    Report Date
    April 5, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 379 MG/DL. PRIOR TO THE HOSPITALIZATION, THE CUSTOMER EXPERIENCED SEIZURES CAUSED BY HIGH BLOOD GLUCOSE LEVELS WHILE SHE WAS TAKING A BATH. THE INSULIN PUMP WAS DROPPED INTO THE TUB. NO WATER CAN BE SEEN UNDER THE SCREEN, BUT THERE IS A CRACK ON THE SCREEN. THE CUSTOMER ALSO STATED THAT THE NURSE AT THE HOSPITAL DETERMINED THAT THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. 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-712LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization