BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2202537 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-82470
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 476MG/DL. THE CUSTOMER STATED THAT HE WOKE UP IN THE MORNING FEELING SICK AND HAD BURNING SENSATION IN THE UPPER EXTREMITIES. THE PARAMEDICS WERE CALLED AT HIS WORK PLACE AND THE CUSTOMER WAS TAKEN TO THE HOSPITAL. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE FOR THE PAST TWENTY FOUR HOURS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 169MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. PERFORMED A HIGH PRESSURE TEST AND THE INSULIN PUMP ALARMED MOTOR ERROR. RAN A DISPLACEMENT AND SELF TEST AND THE TESTS PASSED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization PARADIGM 6 MM CATHETER| UNOMEDICAL INFUSION SET: (B)(4)| QUICK-SET: 23