BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2082699 · Received April 27, 2011

    Report

    Report Number
    3004209178-2011-81242
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE OF 28MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S HUSBAND STATED THAT HIS WIFE CHANGED THE INFUSION SET AT THE MIDDLE OF THE NIGHT AND SHE MAY HAVE BEEN HALF SLEEP. HE STATED THAT HE HAD TO WAKE HER UP AND GAVE HER SOME JUICE. THE CUSTOMER STARTED TO VOMIT AND PARAMEDICS WERE CALLED. RAN A DISPLACEMENT TEST AND THE DEVICE PASSED THE TEST. REVIEWED THE BOLUS HISTORY AND FOUND THAT THE CUSTOMER PROGRAMMED A BOLUS OF 8 UNITS WITH BOLUS WIZARD WHILE CHANGING THE INFUSION SET. IT WAS STATED THAT THE CUSTOMER MAY HAVE GOT THE NUMBERS MIXED, OR SHE WAS HITTING THE BUTTONS AND ACCIDENTLY GAVE HERSELF A VERY LARGE BOLUS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization