BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2871867 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-91353
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 A FEW DAYS AGO DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT HE WAS INCOHERENT AND SWEATING BY THE TIME HER DAUGHTER ARRIVED AND CALLED THEM. THE CALLER STATED THEY TREATED HIS HIGH BLOOD GLUCOSE WITH AN INSULIN DRIP, AND THEN HE DRANK SODA. THE CUSTOMER STATED THAT HE FEELS THE INCIDENT WAS NOT DEVICE RELATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention