BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAS

    MDR report key: 1973837 · Received January 20, 2011

    Report

    Report Number
    2032227-2011-00183
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 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 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 EXPERIENCING LOW BLOOD GLUCOSE DURING THE PAST WEEK. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED HE GAVE HIMSELF A BOLUS OF 6.0 UNITS, AND THE DINNER WAS NOT READY YET. THE CUSTOMER'S GLUCOSE LEVEL DROPPED TO 40MG/DL AND THE PARAMEDICS WERE CALLED TO TREAT THE CUSTOMER. THE CUSTOMER'S BLOOD GLUCOSE AT TIME OF THE CALL WAS 140 MG/DL. THE TIME ON THE DEVICE WAS CORRECT. WHILE VERIFYING THE BASAL RATES FOUND THAT THE CUSTOMER HAD TWO PATTERNS SETTING UP ON THE INSULIN PUMP, WHICH MAY BE CAUSE FOR LOW BLOOD GLUCOSE. ASSISTED THE CUSTOMER TO SELECT THE STANDARD BASAL RATE ON THE DEVICE. RAN A DISPLACEMENT AND SELF TEST AND THE INSULIN PUMP PASSED THE TESTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization