BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1981054 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-80310
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    September 8, 2009
    Report Date
    January 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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. 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. THE PARAMEDICS WERE CALLED AND TOOK HIM TO THE HOSPITAL. THE CUSTOMER STATED THAT HE WAS SLEEPING AND HIS WIFE NOTICED THAT HE WAS MOANING. THE CUSTOMER STATED THAT HIS WIFE TRIED TO WAKE HIM UP AND HE WAS UNRESPONSIVE. THE CUSTOMER STATED THAT HIS BASAL RATE WAS SET TOO HIGH OVERNIGHT. THE CUSTOMER STATED THAT HE ADJUSTED IT, AND HE WAS NOT EXPERIENCED LOW BLOOD GLUCOSE SINCE THEN. NO FURTHER INFO 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-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization