BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2161746 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01651
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 STATED THAT SHE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 248 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER WAS NOT FEELING WELL AT HOME. THE CUSTOMER WAS TREATING HER BLOOD GLUCOSE LEVELS WITH THE INSULIN PUMP, BUT SHE WAS NOT GETTING RESULTS, AND BEGAN VOMITING. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS 440 MG/DL WHEN SHE WAS AT HOME, BUT SHE GAVE HERSELF AN INJECTION BEFORE THE PARAMEDICS ARRIVED. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DIDN'T HAVE THE TUBING CLAMP FOR THE HIGH PRESSURE TEST. THE CUSTOMER ALSO MENTIONED THAT SHE HAD NOTICED THE SCREEN GOING BLANK A COUPLE OF TIMES. THE SCREEN WAS NOT BLANK AT THE TIME OF THE CALL, AND THE CUSTOMER WAS UNABLE TO TROUBLESHOOT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization