BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722RNAP

    MDR report key: 1974370 · Received January 21, 2011

    Report

    Report Number
    2032227-2011-00169
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 5, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS. PRIOR TO THE EVENT, THE CUSTOMER STATED SHE HEARD A NOISE COMING FROM THE INSULIN PUMP, AND THEN IT DELIVERED 60 UNITS OF INSULIN. THE CUSTOMER REMOVED THE INFUSION SET, AND INSULIN WAS COMING OUT OF THE TUBING. TROUBLESHOOTING WAS PERFORMED, AND NO BOLUSES WERE SHOWING IN THE BOLUS HISTORY, BUT 60 UNITS OF INSULIN WERE MISSING FROM THE RESERVOIR. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. FOUND THAT THE CUSTOMER WAS WEARING THE RECALLED LOT 8 INFUSION SETS AT THE TIME OF THE EVENT. ADVISED THAT THE INSULIN PUMP AND INFUSION SETS WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization