BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3180925 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-94881
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER REPORTED THAT THE PARAMEDICS WERE CALLED TO HIS HOME AS HE WAS UNRESPONSIVE FOR ONE HOUR AND A HALF, AND HIS BLOOD GLUCOSE WAS 48MG/DL. THE CALLER STATED THAT HE DECLINED TO BE TAKEN TO THE HOSPITAL. THE CUSTOMER MENTIONED HAVING TWO BOLUSES AT THE SAME TIME, BUT THEN HE STATED THAT HE BOLUSED 11.0 UNITS TO COVER A MEAL EATEN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281341 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention