BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1981852 · Received February 2, 2011

    Report

    Report Number
    2032227-2011-00342
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    October 2, 2010
    Report Date
    January 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2011-00341.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED AFTER BEING PARALYZED DUE TO A FALL. THE CUSTOMER WOKE UP WITH A BLOOD GLUCOSE READING OF 50 MG/DL THAT MORNING. THE CUSTOMER WAS UNCOOPERATIVE, INCOHERENT AND WOULD NOT EAT OR DRINK. THE CUSTOMER THEN ATTEMPTED TO VAULT THE BANISTER OF THEIR STAIRCASE AND LAND ON THE COUCH. THE CUSTOMER MISSED, CRUSHING TWO VERTEBRAE IN HIS SPINE, BREAKING HIS TOE AND SOME RIBS. THE CUSTOMER WAS RUSHED TO THE HOSPITAL FOR TREATMENT. IT WAS ALSO REPORTED THAT SOMETIMES THE SENSOR AND GLUCOSE READINGS ARE 150-200 POINTS OFF. FOUND THAT THE CUSTOMER HAD BEEN WEARING THE SENSOR FOR 11 DAYS. ADVISED OF THE RECOMMENDED TWO TO THREE DAY USE. 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-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization