BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2234057 · Received August 29, 2011

    Report

    Report Number
    2032227-2011-02193
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 16, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THAT SHE WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE LEVELS AND NAUSEA. THE REPORTED BLOOD GLUCOSE READING WAS 900 MG/DL. THE CUSTOMER STATED THAT SHE HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST DAY. THE CUSTOMER WAS ALSO GETTING NO DELIVERY ALARMS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. THE HIGH PRESSURE TEST WAS NOT CONDUCTED AS THE CUSTOMER HAD BEEN GETTING NO DELIVERY ALARMS. THE CUSTOMER STATED THAT THE CANNULA WAS BENT WHEN THE INFUSION SET WAS REMOVED. ADVISED THE CUSTOMER OF ALTERNATE INSERTION SITES. 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-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization