BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2082793 · Received April 28, 2011

    Report

    Report Number
    2032227-2011-01062
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 16, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT HE WAS DRIVING 35 MPH OVER THE SPEED LIMIT WHEN HE EXPERIENCED THE HYPOGLYCEMIA. THE CUSTOMER WAS ON HIS WAY TO A DOCTOR'S APPOINTMENT, BUT DOESN'T REMEMBER ANYTHING. THE CUSTOMER STATED THAT HE ALSO EXPERIENCED A LOW BLOOD GLUCOSE READING OF 26 MG/DL ON (B)(6) 2011, AND THE PARAMEDICS WERE CALLED. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE DISPLACEMENT AND PRIME TESTS. FOUND NO DELIVERY ALARMS IN THE ALARM HISTORY. THE CUSTOMER STATED THAT HE DOESN'T NORMALLY USE THE BOLUS WIZARD FEATURE. THE CUSTOMER STATED THAT HIS HEALTHCARE PROFESSIONAL ADVISED HIM TO LOWER HIS BASAL RATE BY 20%. ADVISED THE CUSTOMER ON THE BENEFITS OF THE BOLUS WIZARD. 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-515RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization