BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202547 · Received August 5, 2011

    Report

    Report Number
    2032227-2011-01976
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 CALLED TO REPORT LOW BLOOD GLUCOSE LEVELS FOR THE PAST TWO DAYS. THE CUSTOMER STATED THAT HE WAS TAKEN TO THE HOSPITAL DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS UNCONSCIOUS, WITH A BLOOD GLUCOSE OF 34 MG/DL WHEN HIS WIFE CALLED THE PARAMEDICS. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE BOLUS HISTORY AND FOUND THAT THE CUSTOMER DELIVERED TWO BOLUSES IN THE MIDDLE OF THE NIGHT. ONE AT 1:42AM FOR 5.3 UNITS AND ANOTHER AT 1:49AM FOR 6.3 UNITS. THE CUSTOMER DID NOT RECALL PROGRAMMING THOSE BOLUSES. FOUND THAT THE CUSTOMER IS NEW TO THE INSULIN PUMP, AND MAY BE OVER DELIVERING FOR HIS BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS ADVISED TO SPEAK WITH HIS HEALTH CARE PROFESSIONAL FOR FURTHER ASSISTANCE AND/OR TRAINING. 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-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization